Ex Parte Crow

Board of Patent Appeals and Interferences

Mar 28, 2011

10998454 (B.P.A.I. Mar. 28, 2011)

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.
10/998,454 11/29/2004 Loren M. Crow 1001.2177101 3942
11050 7590 03/28/2011
SEAGER, TUFTE & WICKHEM, LLC
1221 Nicollet Avenue
Suite 800
Minneapolis, MN 55403
EXAMINER
BOUCHELLE, LAURA A
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
03/28/2011 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 BOSTON SCIENTIFIC SCIMED, INC.
____________________

Appeal 2010-001736
Application 10/998,454
Technology Center 3700
____________________

Before JAMESON LEE, RICHARD TORCZON, and
SALLY GARDNER LANE, Administrative Patent Judges.

LEE, Administrative Patent Judge.

DECISION ON APPEAL

A. STATEMENT OF THE CASE
This is a decision on appeal by an Appellant, whose real party in
interest is Boston Scientific Scimed, Inc. (“Boston Scientific”), under 35
U.S.C. § 134(a) from a final rejection of claims 1-20. We have jurisdiction
under 35 U.S.C. § 6(b). We affirm.

Appeal 2010-001736
Application 10/998,454

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References Relied on by the Examiner
Goldberg et al. (“Goldberg”) 5,152,777 Oct. 6, 1992
Schwartz 6,746,463 Jun. 8, 2004

The Rejections on Appeal
The Examiner rejected claims 1-20 under 35 U.S.C. § 103(a) as
unpatentable over Schwartz and Goldberg.

The Invention
The invention relates to a catheter used to incise or cut an aortic valve
stenosis, i.e., a narrowing or constricting portion within the valve, where a
portion of the blade of the catheter is configured with a blunt tip to prevent
inadvertent incision. (Spec. 1:2-8.) Examples of a blunt tip include a “fine
coil wire,” a “ball shaped element,” or a “protective sheath” which may be
positioned to cover the distal end of the blade so that the tip of the blade is
prevented from incising tissue. (Id. at 3:13-28.)
Claim 1 is representative and reproduced below (App. Br. 14 Claims
App’x.):
1. A cutting device comprising:

a catheter;

an elongated balloon defining an axis, the balloon being
mounted on the catheter for reconfiguration between an inflated
configuration and a deflated configuration;

an elongated blade formed with a cutting edge and having a
distal end and a proximal end, with the proximal end thereof attached
to the balloon to orient the blade in a plane with the axis of the
balloon and to project the cutting edge of the blade in a radial
direction from the axis of the balloon; and
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a blunt tip member at the distal end of the blade to prevent
tissue incision by the distal end of the blade during a movement of the
blade.
B. ISSUE
Did the Examiner correctly determine that the combined teachings of
Schwartz and Goldberg would have led a person of ordinary skill in the art
to implement a blunt tip onto the end of a cutting blade in a device used for
cutting an aortic valve stenosis?
C. PRINCIPLES OF LAW
The test for obviousness is what the combined teachings of those
references would have suggested to one of ordinary skill in the art. In re
Young, 927 F.2d 588, 591 (Fed. Cir. 1991).
D. FINDINGS AND ANALYSIS
The Examiner rejected claims 1-20 as unpatentable over Schwartz and
Goldberg. Claims 1, 9, and 17 are independent claims. Claims 2-8, 10-16,
and 18-20 are ultimately dependent on one of claims 1, 9, and 17. The
dependent claims are argued collectively with the independent claims.
Claims 1 and 9 are drawn respectively to a “cutting device” and a
“device for incising tissue.” (App. Br. 14, 16 Claims App.’x.) Claim 17 is
directed to a “method of incising target tissue with a blade.” (Id. at 17.)
Each of claims 1, 9 and 17 includes a similar feature in connection with the
configuration of a portion of a blade component and at issue with regard to
the rejection on appeal.
In claim 1, the pertinent feature reads (id. at 14):
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a blunt tip member at the distal end of the blade to prevent
tissue incision by the distal end of the blade during a movement of the
blade.

In claim 9, the pertinent feature reads (id. at 16):
a blunt tip member at the distal end of the blade[.]

In claim 17, the pertinent feature reads (id. at 17):
the blade having a blunt tip member at the distal end thereof to
prevent tissue incision by the distal end during movement of the
blade[.]

The Examiner determined that Schwartz discloses a cutting or incising
device and method having all the features of claims 1, 9, and 17, including a
blade, with the exception of a blunt tip member formed at the distal end of
the blade. The Examiner reasoned, however, that in view of the teachings of
Goldberg taken with those of Schwartz, a person of ordinary skill in the art
would have known to implement a blunt member onto the tip of a blade of a
device which is operated within the aortic valve of a patient. (Ans. 3-4.)
Boston Scientific first disputes the Examiner’s determination and
reasoning on the premise that there is “no reasonable expectation of success”
in combining the teachings of the references. (App. Br. 12:6-11.)
According to Boston Scientific, that is so because of the “different natures
and desired results” of the two references. (Id. at 12:12-15.)
Boston Scientific’s argument is unpersuasive. It is not necessary that
two references must have the same nature and desired result for one of
ordinary skill in the art to reasonably expect success in combining their
teachings. Schwartz discloses a system “for incising a stenosis in the aortic
valve of a patient.” (Schwartz Abstract.)
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Schwartz’s Figure 1 illustrates its system and is reproduced below:

Figure 1 depicts a system according to Schwartz’s invention.

As shown in the figure above, system 10 includes a catheter 12, a
balloon 18 (shown inflated), and a plurality of cutting blades 26 (shown as
26a and 26b). (Id. at 3:31-51.) The cutting blades include a sharp cutting
edge 42 and a distal end 40. (Id. at 4:14-19.) Schwartz’ Figure 5 illustrates
the system employed in a patient.
Figure 5 is reproduced below:

Figure 5 depicts Schwartz’s invention positioned within the
ventricle of a patient.
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During the procedure, Schwartz’s device is delivered into a patient’s
ventricle along a guidewire 22. (Schwartz 4:53-56.) When delivered,
balloon 18 is in a deflated configuration such that the material of the balloon
covers the cutting edges of blades 26a and 26b. (Id. at 4:48-51.) Schwartz
recognizes that covering portions of the blades during delivery is important
to “reduce the possibility of an unintended incision of tissue.” (Id. at 4:51-
52.) Once positioned as shown in the figure above, the balloon is then
inflated so as to radially deploy blades 26 and orient cutting edges 42 to
incise the stenosis in aortic valve 54. (Id. at 4:53-58.) The device is then
retracted in the proximal direction toward aorta 56 to perform the incising
action by operation of cutting edges 42. (Id. at 4:58-65.)
Schwartz does not disclose that the distal ends 40 of cutting blades
26a and 26b are formed with a blunt tip, but, as noted above, does describe
that “unintended incision of tissue” is undesirable. Schwartz also states the
following in describing the operation of the cutting structure of its device
(id. at 4:15-17):
[T]his cooperation of structure allows the sharp cutting edge 42 of the
blade 26a, at the distal end 40 of the blade 26a, to extend radially
outward from the axis…

Thus, the cutting surface as described in Schwartz is “cutting edge” 42
and not the distal tip 40 of blade 26a.
Goldberg discloses a device for preventing occlusion in a blood
vessel. (Goldberg Abstract.) Although Goldberg’s device is not intended to
cut portions of the blood vessel, Goldberg recognizes that the presence of
sharpened hooks or tips in such devices presents a hazard that may cause
damage to a vessel wall when the device is positioned within a blood vessel.
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(Id. at 3:39-43.) To alleviate that hazard, Goldberg proposes capping such
tips with blunt rounded balls which minimize the potential for undesired
impaling or puncturing of the vessel walls. (Id. at 6:38-43; 7:4-7.)
In light of the teachings of Schwartz and Goldberg, a person of
ordinary skill in the art would have realized that the distal end of Schwartz’s
blade presents a puncturing hazard of the type recognized by Goldberg as
detrimental. That the devices of Goldberg and Schwartz may have different
functions when inserted into a vessel of a patient is of no moment, as in each
reference a portion of a device presents a similar danger of unintended
cutting of vessel tissue. A skilled artisan would have reasonably expected
that implementing blunt portions, such as the balls of Goldberg, onto the tips
of Schwartz’s blades would be successful in minimizing the risk of
unintended tissue incision by those tips. We reject Boston Scientific’s
argument to the contrary as it does not adequately account for how a person
of ordinary skill in the art would have viewed the combined teachings of
those references.
Boston Scientific also alternatively argues that Schwartz already
incorporates a solution for reducing the risk of unintended incision of tissue
from portions of its blade and that Schwartz’s device is therefore already
“fully capable” of alleviating the problem. (Reply Br. 5:2-9.) According to
Boston Scientific, that means a skilled artisan would not look to any other
teaching for other possible solutions to the problem.
Boston Scientific’s conclusion is misplaced. Schwartz’s disclosure
does not foreclose further inquiry by a skilled artisan into other potential
solutions. The obviousness analysis does not end simply because one
reference, i.e., Schwartz, demonstrates awareness of one possible solution to
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a problem. Rather, where, as here, a rejection is based on the teachings of
multiple references, the test for obviousness is what the combined teachings
of those references would have suggested to one of ordinary skill in the art.
In re Young, 927 F.2d at 591. As discussed above, in light of the combined
teachings of Schwartz and Goldberg, a person of ordinary skill in the art
would have recognized that a blunt tip implemented onto the distal end of a
blade in a device for incising an aortic valve stenosis is a viable mechanism
for minimizing the risk of unintended puncturing of vessel tissue.
Boston Scientific’s arguments have been carefully considered but are
unpersuasive. For the foregoing reasons, we sustain the rejection of claims
1-20 as unpatentable over Schwartz and Goldberg.
E. CONCLUSION
The Examiner correctly determined that the combined teachings of
Schwartz and Goldberg would have led a person of ordinary skill in the art
to implement a blunt tip onto the end of a cutting blade in a device used for
cutting an aortic valve stenosis.
F. ORDER
The rejection of claims 1-20 under 35 U.S.C. § 103(a) as unpatentable
over Schwartz and Goldberg is affirmed.

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).

Appeal 2010-001736
Application 10/998,454

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AFFIRMED

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Suite 800
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