Ex Parte Melsheimer

Patent Trial and Appeal Board

Nov 27, 2012

11318989 (P.T.A.B. Nov. 27, 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.
11/318,989 12/27/2005 Jeffry S. Melsheimer 8627/1095
(PA-5649-RFB)
7123
48004 7590 11/28/2012
BRINKS HOFER GILSON & LIONE/INDY/COOK
BRINKS HOFER GILSON & LIONE
CAPITAL CENTER, SUITE 1100
201 NORTH ILLINOIS STREET
INDIANAPOLIS, IN 46204-4220
EXAMINER
MCEVOY, THOMAS M
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
11/28/2012 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 PATENT TRIAL AND APPEAL BOARD
________________

Ex parte JEFFRY S. MELSHEIMER

________________

Appeal 2011-006739
Application 11/318,989
Technology Center 3700
________________

Before TONI R. SCHEINER, LORA M. GREEN, and JOHN G. NEW,
Administrative Patent Judges.

NEW, Administrative Patent Judge.

DECISION ON APPEAL

Appeal 2011-006739
Application 11/318,989

2
SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 17-19 and 21-36 as unpatentable
under 35 U.S.C. § 103(a). Claims 17-19, 21-25, and 27-36 are rejected
under 35 U.S.C. § 103(a) as being obvious over Falotico et al.
(US 2003/0060877 A1, March 27, 2003) (“Falotico”), Weber (US
2004/0133223 A1, July 8, 2004) (“Weber”), and Shaw et al. (US
2004/0215223 A1, October 28, 2004) (“Shaw”).
The Examiner additionally rejected, in an alternate interpretation,
claims 18 and 25-27 under 35 U.S.C. 103(a) as being obvious over Falotico,
Weber, Shaw, and Yan (US 6,066,156, May 23, 2000) (“Yan”).
1

We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

STATEMENT OF THE CASE
Appellant’s invention is directed to a cutting device for use with a
balloon angioplasty catheter of the type having a catheter shaft and an
inflatable balloon disposed at a distal portion of the catheter shaft.
Abstract.

GROUPING OF CLAIMS

1
Claims 18 and 25-27 were rejected on this ground in the Examiner’s Final
Rejection and are the claims addressed by Appellant’s Brief with respect to
those rejections. The Examiner’s Answer rejected claims 18 and 25-30 on
this ground, however we address herein only claims 18 and 25-27 with
respect to this argument.
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Because Appellant only presents arguments as to independent claim
17, we focus our analysis on that claim, and claims 18, 19, 21-25, and 27-36
stand or fall with that claim. 37 C.F.R. § 41.37(c)(1)(vii).
Appellant also does not present separate arguments as to claims 18
and 25-27 . App. Br. 10. We therefore treat claim 18 as representative, and
claim25-27 stand or fall with that claim.

ISSUES AND ANALYSES
Issue 1: Rejection of Claims17-19 and 21-25, and 27-36.

Claim 17 recites:
17. An angioplasty catheter assembly for cutting
restrictions in a body vessel, said assembly comprising:

a balloon angioplasty catheter comprising a catheter shaft
having an inflation lumen, and an inflatable balloon secured to
a distal portion of the shaft, said balloon having an outer
circumferential portion, an interior portion of said balloon in
fluid communication with said inflation lumen for receiving an
inflation fluid therethrough; and

a generally cylindrical sleeve having a proximal end and
a distal end, said sleeve sized for mounting on said outer
circumferential portion of the balloon when the balloon is in an
uninflated condition, at least a portion of said sleeve being
radially expandable upon inflation of said balloon, said sleeve
including a plurality of cut-out portions sized and arranged
therealong to facilitate said sleeve expansion upon inflation of
said balloon, and a plurality of raised portions projecting
radially outwardly from an outer surface of said sleeve, said
raised portions oriented and configured along said outer surface
for cutting said body vessel restrictions upon inflation of said
balloon, at least some of said cut-out portions and raised
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portions having a generally curved longitudinal configuration
along said outer surface.

App. Br. 13.

Issue

Appellant argues that the Examiner erred in finding that claim 17 is
unpatentable under 35 U.S.C. § 103(a) as being obvious over Falotico,
Weber, and Shaw. App. Br. 10. Specifically, Appellant argues that the
Examiner erred because Falotico teaches away from claim 17’s limitation
of a sleeve having a raised cutting surface. Id. The issue is thus whether
the Examiner properly combined Falotico with Weber and Shaw in finding
that the references disclose or suggest all of the limitations of claim 17.

Analysis
Appellant argues that Falotico teaches the use of a stent together with
various drug or drug combinations applied to the interior of a vessel wall as
a means of addressing adverse outcomes that may occur incidental to
angioplasty as a result of the introduction of the stent. App. Br. 8.
According to Appellant, Falotico teaches the method, well-known in the art,
of using a balloon catheter to clear an obstructed vessel and of placing a
stent in the cleared vessel to ensure that it remains open. Id. Therefore,
Appellant contends, Falotico is concerned with clearing vessel obstructions
and thereafter treating vascular injury that may be a consequence of the
clearing step. Id. Appellant argues that the teachings of Falotico provide
no disclosure or suggestion for using a cutting device as disclosed by
Appellant’s claim 17 and, in fact, the use of cutting devices proceeds in a
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direction contrary to Falotico’s concern for minimizing damage to the
interior vessel wall. Id. Consequently, asserts Appellant, Falotico not only
fails to teach or suggest any benefit from such a raised cutting, but rather,
by its teaching of drugs to address such concerns, teaches away from such
use. App. Br. 9. Appellant argues that Falotico’s emphasis on addressing a
biological organism’s adverse reaction to the introduction of a medical
device therefore teaches away from the introduction of a sleeve having a
raised, cutting surface. App. Br. 9-10.
The Examiner answers that the primary intent of Falotico is to
combine Falotico’s invention (drug coating) with implantable medical
devices which may cause damage, such as stents. Ans. 7 (citing Falotico,
¶¶ [0017], [0067]-[0069], [0073], and [0074]). Furthermore, the Examiner
finds that the primary intent of Weber is to provide a stent with cutting
elements to ease the force of expansion into a calcified region. Ans. 7
(citing Weber, ¶ [0051]). The Examiner similarly finds that the curved
cutting elements disclosed by Shaw help dilate a stenosis in order to prevent
vessel injury and avoid using a separate cutting/dilating balloon prior to
stent expansion. Ans. 7 (col. 1, ll. 22-44). The Examiner finds that the
stent disclosed by Falotico would benefit from the cutting elements of either
reference, easing expansion into a calcified region and causing better
dilation of the stenosis. Ans. 7-8. The Examiner concludes that a person of
ordinary skill in the art would recognize that nearly any stent, including that
of Falotico, would benefit from the cutting elements taught by Weber or
Shaw. Ans. 8.
We are persuaded by the Examiner’s reasoning and adopt it as our
own. “A reference may be said to teach away when a person of ordinary
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skill, upon reading the reference, would be discouraged from following the
path set out in the reference, or would be led in a direction divergent from
the path that was taken by the applicant.” In re Gurley, 27 F.3d 551, 553
(Fed. Cir. 1994). We agree with the Examiner’s finding that nothing in
Falotico would discourage a person of ordinary skill in the art of treating
occluded vessels from combining the teaching of Falotico with that of
Weber and Shaw. To the contrary, we find that a person of ordinary skill in
the contemporaneous art would have likely been encouraged to combine the
teachings of Falotico with those of Shaw and Weber as a means of
ameliorating any damage to the inner wall of the vessel from the cutting
surfaces on the external surface of the stent. Consequently we conclude
that the Examiner did not err in combining the teachings of Falotico with
those of Weber and Shaw.

Issue 2: Rejection of Claims 18 and 25-27.

Claim 18 recites:
18. The assembly of claim 17, wherein said proximal
end of said sleeve is affixed to a proximal end portion of said
balloon, and said distal end of said sleeve is affixed to a distal
end portion of said balloon.

App. Br. 13.

Issue
Appellant notes that Yan was employed as a prior art reference for
teaching that a balloon and stent should be adhesively affixed in order to
prevent stent movement or detachment. App. Br. 11. We therefore address
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the question of whether the Examiner properly concluded that the
combination of Falotico, Weber, Shaw, and Yan discloses or suggests all of
the limitations of claim 18.

Analysis
Appellant argues that Yan’s teachings have little in common with
Appellant’s claimed invention, either in general, or with specific reference
to an adhesive. Id. Appellant contends that, rather than teaching affixation,
the import of Yan is to teach controlled detachment of a stent from a
balloon via a temperature-activated adhesive. Id. Therefore, according to
Appellant, a skilled artisan would not combine this reference with the
teachings of Falotico, Weber, and Shaw and expect to achieve a catheter
assembly as disclosed by the limitations of claim 18 reciting “wherein …
said … sleeve is affixed to a … portion of said balloon.” Id.
The Examiner answers that the temporary affixation disclosed by
Yan is within the scope of the term “affixed,” as recited by claim 18
because that term, as employed within the limitation of the claim, does not
provide any indication of permanence. Id. The Examiner finds that Yan
discloses that the balloon and stent should be adhesively affixed in order to
prevent movement or detachment of the stent from the catheter at an
inopportune or unforeseen instant. Id. The Examiner finds further that the
device disclosed by Falotico is a stent mounted to a balloon catheter. Id.
Therefore, the Examiner concludes, a person of ordinary skill would be
motivated to combine the teachings of Yan and Falotico. Id.
We are persuaded by the Examiner’s reasoning and adopt it as our
own. We agree with the Examiner’s finding that Yan’s disclosure of a stent
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affixed to the balloon is within the scope of the term “affixed” as employed
by the limitations of claim 18. We therefore find that the Examiner did not
err in finding that a person of ordinary skill in the contemporaneous art
would find that the invention recited in claim 18 would be obvious over the
combination of Falotico, Weber, Shaw, and Yan.

DECISION
The Examiner’s rejections of claims 17-19 and 21-36 are 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)(1). See 37 C.F.R.
§ 1.136(a)(1)(iv) (2011).

AFFIRMED

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