Ex Parte Van Heugten et al

Board of Patent Appeals and Interferences

Aug 1, 2012

11288745 (B.P.A.I. Aug. 1, 2012)

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.
11/288,745 11/28/2005 Anthony Y. Van Heugten 60465-034 5852
59582 7590 08/01/2012
DICKINSON WRIGHT PLLC
2600 WEST BIG BEAVER ROAD
SUITE 300
TROY, MI 48084-3312
EXAMINER
SIMPSON, SARAH A
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
08/01/2012 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)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ANTHONY Y. VAN HEUGTEN, ROD A. SHIPMAN,
and PAUL SHABTY
__________

Appeal 2011-005573
Application 11/288,745
Technology Center 3700
__________

Before ERIC GRIMES, FRANCISCO C. PRATS, and
JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a medical
device, which the Examiner has rejected as obvious. We have jurisdiction
under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
The Specification states that “a need exists to develop a safe and
effective means for sealing the arterial wall following arteriotomy
procedures that allows the patient to quickly return to normal activity”
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(Spec. 2, ¶ 6). The Specification discloses “an arterial closure device that
aids in the effective and efficient deposit of a clotting agent to the site of a
puncture or small incision in the wall of a vein or artery” (id. at 4, ¶ 13).
The clotting agent can be, for example, fibrin sealant (id. at 9, ¶ 34).
Claims 1-21 are on appeal. Claim 1 is representative and reads as
follows:
1. An arterial closure device comprising:
a body having a first port and a second port;
a catheter having proximal and distal ends and extending from said
body and defining a first lumen in operative communication with said first
port and a second lumen in operative communication with said second port;
a first balloon positioned adjacent said distal end of said catheter and
operatively coupled to said first lumen to receive a fluid through said first
port to expand said first balloon;
a second balloon spaced from said first balloon a predetermined
distance and operatively coupled to said second lumen to receive a clotting
agent through said second port to inflate said second balloon, said clotting
agent configured to inflate said second balloon with sufficient pressure to
disrupt adjacent tissue to form a cavity; and
at least one slit disposed in said second balloon expandable between
an open position and a closed position in response to inflation of said second
balloon such that the clotting agent is ejected into the cavity through said slit
in said open position.

The claims stand rejected under 35 U.S.C. § 103(a) as follows:
• Claims 1-7 and 14-21 based on Myers
1
and Shaffer
2
(Answer 4);
• Claims 8-10 based on Myers, Shaffer, and Noda
3
(Answer 9);

1
Myers et al., US 5,725,551, issued Mar. 10, 1998.
2
Shaffer et al., US 5,049,132, issued Sept. 17, 1991.
3
Noda, US 6,669,711 B1, issued Dec. 30, 2003.
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• Claim 11 based on Myers, Shaffer, Noda, and Lennox
4
(Answer
11); and
• Claims 12 and 13 based on Myers, Shaffer, and Barak
5
(Answer
12).
I.
Issue
The Examiner has rejected claims 1-7 and 14-21 as obvious in view of
Myers and Shaffer (Answer 4). The Examiner finds that Myers discloses an
arterial closure device that meets the limitations of claim 1 except that
Myers does not disclose a second balloon comprising at least one slit (id.).
The Examiner finds that Shaffer discloses a device comprising a balloon
with slits in it that open in response to inflation of the balloon to administer a
therapeutic agent such as fibrin glue (id. at 5). The Examiner concludes that
it would have been obvious “to modify the arterial closure device of Myers
et al. with an expandable balloon containing at least one slit such that the
clotting agent is ejected through said slit,” because “[d]oing so would
enhance controlled delivery as well as use positive pressure to inject
medication to a treatment site, resulting in less blockage of the medication
flow” (id.).
Appellants contend that Shaffer’s device includes an inner balloon to
apply force to artery walls during angioplasty in addition to the exterior, slit-
containing balloon, which is a non-force applying balloon that applies
medicine without pressure (Appeal Br. 9), in contrast to the claimed

4
Lennox, US 6,280,411 B1, issued Aug. 28, 2001.
5
Barak, US 6,048,358, issued Apr. 11, 2000.
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invention, which “claims the use of a second balloon 58 that both expands to
disrupt surrounding tissue as well as disperse clotting agent or similar
medicine” (id.). Appellants argue that Shaffer “teaches away from having
the medicine dispersing balloon also act as a pressure balloon due to the
pressure generated by the medicine” (id. at 9-10).
The issue presented is: Does the evidence of record support the
Examiner’s conclusion that it would have been obvious to combine the slit-
containing balloon taught by Shaffer with Myers’ arterial closure device?
Findings of Fact
1. The Examiner finds that Myers discloses an arterial closure device
comprising the body, catheter, ports, lumens, and first balloon required by
claim 1 (Answer 4). Appellants do not dispute this finding.
2. The Examiner finds that Myers’ device also includes “a second
balloon (54) spaced from said first balloon a predetermined distance and
operatively coupled to said second lumen to receive a [ ] clotting agent (36)
through said second port to inflate said second balloon (column 5, lines 60-
62, 64-67; fig. 1A)” (Answer 4).
3. Myers discloses an arteriotomy closure device (Myers, col. 2, ll.
57-59) that includes a body with multiple ports (id., Fig. 1A, elements 30
and 32a-d), a catheter with multiple lumens each in communication with a
port (id., Fig. 1B), a first balloon adjacent the distal end of the catheter and
operatively coupled to a lumen (id., Fig. 3, element 44), and a second
balloon spaced from the first balloon and operatively coupled to a second
lumen (id., Fig. 3, element 54).
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4. In Myers’ apparatus, inflation of the second balloon creates a
cavity on the exterior surface of the artery, for depositing a sealant material
(id. at col. 6, ll. 3-7).
5. In Myers’ apparatus, the delivery means for the sealant material
can be a separate opening in fluid communication with a separate lumen, via
which a liquid sealant can be delivered into the cavity formed by the second
balloon (id. at col. 6, ll. 18-27).
6. The liquid sealant material can be fibrin glue (id. at col. 6, ll. 41-
49).
7. Shaffer discloses “a balloon catheter [that] may be used for PTCA
or other, similar procedures for enlarging arteries and the like, but it may be
used for any other purpose as well” (Shaffer, col. 2, ll. 10-13).
8. Shaffer discloses that its catheter preferably includes a first balloon
that is aperture-free and a second balloon having apertures through its wall
(id. at col. 2, ll. 28-40).
9. Shaffer discloses that the apertures can be holes (id. at col. 2, ll.
42-51) or slits (id. at col. 3, ll. 42-53; col. 6, l. 67 to col. 7, l. 4).
10. Shaffer discloses that the apertures can have diameters of about
0.01 to 0.05 inch (id. at col. 2, ll. 49-50).
11. The “second balloon is positioned generally radially outwardly
about the first balloon in telescoping relation therewith. Accordingly,
pressure from the first balloon can be used to outwardly expand the second
balloon.” (Id. at col. 2, ll. 53-56.)
12. Shaffer discloses that its
catheter may be used in a PTCA procedure to provide a
conventional high pressure expansion of the stenosis site with
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the first balloon. . . . This may be followed by deflation of the
first balloon to any desired degree, and the addition of
medication such as heparin solution to the area between the first
and second balloons . . . from where the heparin flows
outwardly through the apertures, while any desired pressure is
administered by any combination of pressurization of the
medication itself and the first balloon.
(Id. at col. 2, l. 61 to col. 3, l. 3.)
13. Shaffer discloses that “the therapeutic agent may include a
biological adhesive such as . . . fibrin glue” (id. at col. 4, ll. 8-10).
Analysis
Myers discloses an arterial closure device that meets the limitations of
claim 1 except for one feature: rather than ejecting clotting agent through
slits in the second balloon upon inflation of that balloon with clotting agent,
Myers creates a cavity with a balloon lacking apertures, then administers
clotting agent through a separate lumen that communicates with an opening
that is separate from the balloon. However, Shaffer discloses a device that
includes two balloons: an inner balloon that can provide a conventional,
high-pressure expansion (FFs 11,12) and an outer balloon that includes
apertures (FFs 8, 11), which can be slits (FF 9), that is used to deliver a
medication such as a fibrin glue (FFs 12, 13).
We agree with the Examiner (Answer 5, 14) that it would have been
obvious to replace the balloon-and-separate-opening elements of Myers’
device with the inner-and-outer-balloons elements of Shaffer’s device,
because both arrangements provide a mechanism for creating a cavity by
inflation of a balloon, and a mechanism for administering a therapeutic agent
such as fibrin glue. The combination thus requires simply replacing one set
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of elements with another set that was taught in the prior art to carry out the
same or similar functions. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
416 (2007) (“[W]hen a patent claims a structure already known in the prior
art that is altered by the mere substitution of one element for another known
in the field, the combination must do more than yield a predictable result.”)
(citing United States v. Adams, 383 U.S. 39, 50-51 (1966)).
Appellants argue that “the present invention teaches and claims the
use of a second balloon 58 that both expands to disrupt surrounding tissue as
well as disperse clotting agent or similar medicine. This is not taught or
suggested by Shaffer or Myers alone or in combination.” (Appeal Br. 9.)
Appellants argue that using the second, exterior balloon of Shaffer to exert
pressure “would run counter to the claimed advantages of the Shaffer
reference (see col. 6, 28-35) where the medicine can be applied without
pressure” (id. at 9) and therefore Shaffer “teaches away from having the
medicine dispersing balloon also act as a pressure balloon due to the
pressure generated by the medicine” (id. at 9-10).
This argument is not persuasive. Claim 1 states that the second
balloon is “spaced from said first balloon a predetermined distance and
operatively coupled to said second lumen to receive a clotting agent through
said second port to inflate said second balloon, said clotting agent
configured to inflate said second balloon with sufficient pressure to disrupt
adjacent tissue to form a cavity” (claim 1). Claim 1 also requires “at least
one slit disposed in said second balloon expandable between an open
position and a closed position in response to inflation of said second balloon
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such that the clotting agent is ejected into the cavity through said slit in said
open position” (id.).
Appellants do not dispute that the combination of references suggests
a device comprising a second balloon spaced from the first (distal) balloon
and coupled to a separate lumen. Thus, the references would have made
obvious “a second balloon spaced from said first balloon a predetermined
distance and operatively coupled to said second lumen to receive a clotting
agent through said second port to inflate said second balloon,” so as to
receive a clotting agent or some other fluid to inflate the balloon.
With regard to the claim language stating that the second balloon is
operatively coupled to a lumen “to receive a clotting agent . . . configured to
inflate said second balloon with sufficient pressure to disrupt adjacent tissue
to form a cavity,” we conclude that this claim language does not impose any
meaningful limitation on the claimed invention. First, the claims are
directed to a device, not a kit comprising a device and a particular clotting
agent. Second, neither Appellants’ arguments nor the Specification provide
any guidance regarding how a clotting agent must be “configured” in order
to provide sufficient pressure to inflate a balloon in such a way as to form a
cavity in tissue. Since it reasonably appears that a balloon could be inflated
equivalently with any fluid, this claim language does not appear to limit the
claimed device in any way.
Finally, claim 1 requires that the slits in the second balloon are
“expandable between an open position and a closed position in response to
inflation of said second balloon such that the clotting agent is ejected into
the cavity through said slit in said open position.” Shaffer’s balloon meets
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this limitation, since Shaffer discloses that its apertures, including slits, open
under pressure to allow passage of medication, and close when the pressure
ceases (see Shaffer, col. 2, ll. 42-51; col. 3, ll. 41-53). The combination
posited by the Examiner thus meets all the limitations of claim 1.
With regard to claim 4, Appellants argue that the cited references do
not suggest the slit sizes required by that claim (Appeal Br. 11-12).
However, Shaffer discloses that its apertures can have a diameter of 0.01-
0.05 inch (FF 10), which the Examiner calculates to be 0.254 to 1.27 mm
(Answer 15), and therefore within the size range recited in claim 4.
Appellants’ argument is therefore unpersuasive.
With regard to claim 17, Appellants repeat the arguments they made
for the patentability of claim 1. These arguments are addressed above, and
are unpersuasive with respect to claim 17 for the same reason.
With regard to claim 21, Appellants argue that
[i]t is not taught, suggested, nor even possible utilizing the
structure described in Shaffer to arrive at the unique claimed
structure wherein the second balloon is inflated to generate a
cavity in surrounding tissue with a first pressure of the clotting
agent (60) and then increasing that pressure to open up the slits
(62) and disperse the clotting agent.

(Appeal Br. 16).
This argument is also unpersuasive. Claim 21 is directed to the device
of claim 1, “wherein said second balloon and said slit are configured such
that said second balloon is inflated with a first pressure and said slit is
moved into said open position with a second pressure, said second pressure
greater than said first pressure” (claim 21). Thus, claim 21 does not require
that inflation of the second balloon creates a cavity in tissue, only that the
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slits in the device are configured to allow some degree of inflation of the
balloon under a certain fluid pressure, and to open in response to a higher
fluid pressure. Shaffer teaches this limitation (see Shaffer, col. 2, ll. 42-51;
col. 3, ll. 41-53).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that it
would have been obvious to combine the slit-containing balloon taught by
Shaffer with Myers’ arterial closure device.
II.
The Examiner has rejected claims 8-10 as obvious based on Myers,
Shaffer, and Noda (Answer 9); claim 11 as obvious based on Myers, Shaffer,
Noda, and Lennox (Answer 11); and claims 12 and 13 as obvious based on
Myers, Shaffer, and Barak (Answer 12). Appellants have waived the
opportunity to present additional arguments with respect to these rejections.
See Appeal Br. 16-17. Therefore, for the reasons discussed above with
respect to claim 1, and based on the findings and conclusions set out in the
Answer, we affirm the rejections under 35 U.S.C. § 103(a) of claims 8-13.
SUMMARY
We affirm all of the rejections on appeal.
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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