Ex Parte Stenzel

Board of Patent Appeals and Interferences

Aug 8, 2012

11166539 (B.P.A.I. Aug. 8, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ERIC B. STENZEL
__________

Appeal 2011-007171
Application 11/166,539
Technology Center 3700
__________

Before ERIC GRIMES, MELANIE L. McCOLLUM, and
ULRIKE W. JENKS, Administrative Patent Judges.

JENKS, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 involving claims
directed to a rapid-exchange pre-dilator catheter. We have jurisdiction under
35 U.S.C. § 6(b). We reverse.
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STATEMENT OF THE CASE
The invention is directed to a predilation device that can be used to
dilate occluded vessels that can be difficult to cross with a guide wire alone
due to an obstruction. This device provides an alternative to rotational
atherectomy devices or invasive bypass surgery. (Spec. 1, ll. 12-20.) The
disclosed predilation device “may be guided to the lesion using the
guidewire. . . . The catheter shaft may be rotated and advanced thereby
causing the tip to remove lesion material and predilate the lesion” (id. at 2,
ll. 26-29). The device can also comprise “a rapid exchange clip having a
catheter lumen extending therethrough and a guidewire lumen extending
therethrough” (id. at 2, l. 31 to 3, l. 1).
Claims 1-3, 5-7, 10, 11, 16-21, 23, and 24 are on appeal, and can be
found in the Claims Appendix of the Appeal Brief (App. Br. 24-26). Claims
1, 17, and 24 are independent claims. Claim 1 is representative of the claims
on appeal, and reads as follows (emphasis added):
1. A predilator comprising:
a catheter, the catheter comprising a catheter shaft defining a
central axis, the shaft having a distal tip, the distal tip having helical
threadings; and
a rapid exchange element having a first internal passageway
and a second internal passageway, a portion of the catheter shaft
passing through the first internal passageway;
wherein the rapid exchange element is rotatably coupled to the
shaft allowing rotation of the shaft about its central axis when the
rapid exchange element and at least a portion of the shaft are oriented
within a body vessel.

The following ground of rejection is before us for review:
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The Examiner has rejected claims 1-3, 5-7, 10, 11, 16-21, 23, and 24
under 35 U.S.C. § 103(a) as unpatentable over Nash1 in view of Monroe2
and further in view of Lesh.3

ISSUE
“Monroe et al disclose several manners of fixing a component to the
shaft of a catheter” (Ans. 4). The Examiner asserts that one of these
possibilities would “permit the shaft to rotate within the rapid exchange
element” (id.). The Examiner takes the position that “while friction fitting
two portions together secures two articles together, it permits a degree of
movement under application of force and therefore would permit rotation of
the two coupled portions.” (Id. at 8.)
Appellant contends that the Examiner has not established that the
friction fitting of Nash necessarily allows for rotation (Reply. Br. 3), or that
rotation is “inherent in the protrusion and recess fitting taught by Monroe”
(id.).
The issue with this rejection is whether the references produce a
catheter attachment that can rotate around a catheter shaft.

FINDINGS OF FACT
FF1. Nash disclosed a catheter with a connecting sleeve. “The sleeve is
secured in place by any suitable means, e.g., an adhesive, by friction fit, etc.

1 Nash et al., US 6,517,518 B2, issued Feb. 11, 2003.
2 Monroe et al., US 2002/0052641 A1, published May 2, 2002.
3 Lesh et al., US 5,921, 982, issued Jul. 13, 1999.
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Moreover, the sleeve may be integrally formed on the distal end portion of
the catheter.” (Nash, col. 8, ll. 10-13.)
FF2. Monroe disclosed attaching a catheter tip to a catheter. One of the
ways to attach the distal tip to the catheter requires the catheter to include
outward protrusions. These outward protrusions can be “formed as a series
of discrete outward protrusions, as a single continuous annular ring, or as a
series of discrete annular ring segments.” (Monroe 4, ¶0043.) The distal tip
will correspondingly contain an inner dent or recess that can “include a
series of discrete recesses, a single annular channel, or a series of annular
channel segments.” (Id.) The inner recess preferably matches the outward
protrusions. (Id.)
FF3. Monroe disclosed that “[s]leeve 36 can be secured to inner tube 32
using heat bonding, adhesives, or solvent welding, using methods well
known to those skilled in the art.” (Monroe 3, ¶0034.)
FF4. Monroe disclosed “[b]arbs 84 can bite into proximal sleeve portion 92
to secure tip 86 to inner tube 82 or alternatively, sleeve portion 92 can form
around barbs 84 to provide a mechanical lock.” (Monroe 3, ¶0041.)

PRINCIPLES OF LAW
“The Patent Office has the initial duty of supplying the factual basis
for its rejection. It may not . . . resort to speculation, unfounded assumptions
or hindsight reconstruction to supply deficiencies” in the cited references. In
re Warner, 379 F.2d 1011, 1017 (CCPA 1967). “[R]ejections on
obviousness grounds cannot be sustained by mere conclusory statements;
instead, there must be some articulated reasoning with some rational
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underpinning to support the legal conclusion of obviousness.” In re Kahn,
441 F.3d 977, 988 (Fed. Cir. 2006), cited with approval in KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 417-18 (2007).

ANALYSIS
The Examiner takes the position that Nash disclosed a catheter sleeve
that has a first internal passageway and a second internal passageway, with a
guide wire that passes through the second internal passageway (Ans. 3).
“Nash et al fail to explicitly teach or disclose that the coupling allows the
shaft to rotate about its central axis, or that the distal tip of the shaft has
helical threadings.” (Ans. 3-4.) The Examiner looks to Monroe for a
method of coupling a component to a catheter shaft that allows for rotation
around the catheter shaft. The Examiner takes the position “Monroe et al
disclose several manners of fixing a component to the shaft of a catheter,
including the protrusion and recess of Figure 7, which would allow the
catheter shaft to rotate within the tip, and therefore also permit the shaft to
rotate within the rapid exchange element.” (Id. at 4.)
In making a rejection based on obviousness the Examiner has to
articulate some motivation or a reason why persons of ordinary skill in the
art would have been prompted to combine the prior art to have made the
claimed invention. KSR Int’l Co. v. Teleflex Inc. 550 U.S at 418. The
Examiner asserts that “it would have been obvious to one having ordinary
skill in the art to use the protrusion and recess of Monroe et al in order to
attach the rapid exchange element and catheter shaft of Nash et al because it
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is simply one of many suitable means which could be used to attach the two
components to one another.” (Ans. 4, 5-6.)
The examiner notes that, as Nash et al and Monroe et al are not
considered to be fixed connections by the examiner (as, again, friction
fit connections allow for a degree of movement provided enough force
is applied), the use of the protrusion and recess structure of Monroe et
al in combination with device of Nash et al would prevent any
potential translation of the connector along the longitudinal axis
during rotation of the connector about the catheter, and no portion of
the connection scheme of Nash et al would need to be omitted to
produce the above combination and result.

(Id. at 9) (emphasis added.)
Appellant contends that neither Nash nor Monroe taught or suggested
a catheter coupling that is rotatable. Monroe taught that “’sleeve 36 is
disposed over inner tube distal region 40 and is affixed to inner tube 32 as
indicated at 58 ....Sleeve 36 can be secured to inner tube 32 using heat
bonding, adhesives, or solvent welding, using methods well known to those
skilled in the art.’” (App. Br. 12.) Appellant further emphasizes that the
Monroe couplings are fixed because “‘[b]arbs 84 can bite into proximal
sleeve portion 92 to secure tip 86 to inner tube 82 or alternatively, sleeve
portion 92 can form around barbs 84 to provide a mechanical lock’” (id.).
We agree with Appellant, the Examiner has not set out a prima facie
case. The Examiner has not provided any persuasive reasoning why the
ordinary artisan would arrive at a rapid exchange element that can allow the
catheter shaft to rotate by combining Nash and Monroe. A rejection for
obviousness must include “articulated reasoning with some rational
underpinning to support the legal conclusion.” KSR Int’l Co. v. Teleflex Inc.,
550 U.S. at 418, quoting In re Kahn, 441 F.3d at 988. The Examiner takes
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the position that “while friction fitting two portions together secures two
articles together, it permits a degree of movement under application of force
and therefore would permit rotation of the two coupled portions.” (Ans. 8.)
“The examiner notes that the conclusion of rotatability was based on the
concept of friction fit introduced in Nash et al, permitting for a degree of
movement as described above, and the lack of obstruction in the Monroe et
al device should one rotate the components against one another.” (Id. at 9.)
We are not persuaded by the Examiner’s reasons. The Examiner
admits that “Nash et al fail to explicitly teach or disclose that the coupling
allows the shaft to rotate about its central axis.” (Ans. 3-4.) Nash provided
a catheter coupling that is “secured in place by any suitable means.” (FF1.)
Nash disclosed that the catheter may be secured by means of an adhesive, or
friction fit, or by making the coupling an integral part of the catheter. (FF1.)
Because Nash disclosed that the coupling can be made as an integral part of
the catheter, we find this teaches that the attachment of the coupling to the
catheter is intended to be a fixed and rigid coupling that would not provide
any movement (or rotation) in the Nash construction.
Monroe disclosed several methods of attaching a distal tip to a
catheter. (FF2.) Most of Monroe’s methods of attaching the tip to the
catheter will result in a rigid non-rotatable coupling. The methods of
attachment include heat bonding, adhesives, solvent welding, and the use of
a mechanical lock, none of which provide a rotatable coupling. (FF3, FF4.)
The Examiner specifically directed attention to Figure 7 of Monroe as
showing a coupling that is made of a protrusion and recess that would
“permit the shaft to rotate within the rapid exchange element.” (Ans. 4.)
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We find that Monroe in the context of Figure 7 disclosed that the protrusions
can be made as a series of protrusions, which would not result in a coupling
that could be rotated; or the protrusion could be formed as a single annular
ring, which might result in a coupling that can rotate. However, the
Examiner has not pointed to anything in Monroe as evidence that rotation of
the distal tip around the catheter axis is a desirable goal or result. We find
that the Examiner has not shown that the combination of Nash and Monroe
would lead the ordinary artisan to arrive at a catheter clip that allows the
shaft of the catheter to rotate. The Examiner has not provided a sound
rationale to combine Nash and Monroe to arrive at the instantly claimed
“rapid exchange element [being] rotatably coupled to the shaft” of a
catheter. Lesh does not disclose a catheter coupling, and thereby does not
add any insight to a catheter coupling allowing rotation of a catheter shaft.
We find that the Examiner has not set out a prima facie case based on these
references.

CONCLUSION OF LAW
The evidence on this record fails to support Examiner's finding that
the combination of Nash in view of Monroe and further in view of Lesh
teaches or suggests Appellant’s claimed invention. The rejection of claim 1
under 35 U.S.C. § 103(a) as being obvious is reversed. The other
independent claims (claims 17 and 24) also require a rapid exchange element
rotatably coupled to a shaft. We therefore reverse the rejection of claims 1-
3, 5-7, 10, 11, 16-21, 23, and 24 under 35 U.S.C. § 103(a).

Appeal 2011-007171
Application 11/166,539

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SUMMARY
We reverse the rejection of claims 1-3, 5-7, 10, 11, 16-21, 23, and 24
under 35 U.S.C. §103(a) as unpatentable over Nash in view of Monroe and
further in view of Lesh.

REVERSED

cdc