Ex Parte Wilkowske et al

Patent Trials and Appeals Board

Apr 9, 2019

13625053 - (D) (P.T.A.B. Apr. 9, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/625,053 09/24/2012
55962 7590
Wiley Rein LLP
Patent Administration
1776 K Street, NW
Washington, DC 20006
04/11/2019
FIRST NAMED INVENTOR
Eric John Wilkowske
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
OB-0466USC6/82410.0608 9157
EXAMINER
NGUYEN, HUONG Q
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
04/11/2019 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
ptodocket@wileyrein.com
ASJM_Patents@abbott.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ERIC JOHN WILKOWSKE, ALLAN MANUEL FUENTES,
XIAOPING GUO, XUAN YEN KHIEU, LINDA KAY NEMEC,
and RICHARD E. STEHR 1
Appeal2018-004890
Application 13/625,053
Technology Center 3700
Before DEMETRA J. MILLS, ERIC B. GRIMES, and
FRANCISCO C. PRATS, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
apparatus such as a steerable catheter, comprising a flexible tubular body,
which have been rejected as obvious. We have jurisdiction under 35 U.S.C.
§ 6(b).
We reverse.
1 Appellants identify the Real Party in Interest as St. Jude Medical, Atrial
Fibrillation Division, Inc. Appeal Br. 2.
Appeal2018-004890
Application 13/625,053
STATEMENT OF THE CASE
The Specification discloses that deflection wires for steerable
catheters have been embedded in thermoplastic material, which allows the
wires to create their own lumens, but results in wire lumens of
approximately the same diameter as the wires. Spec. ,r,r 3--4. Friction
between the wires and the lumens causes problems when the catheters are
used. Id. ,r 4.
The Specification discloses an apparatus made by "pre-extruding an
inner layer of the body from a thermoplastic polymer .... If wire lumens
were not integrally formed in the inner layer when pre-extruded, then two
polymer spaghetti tubes, each with wire lumens, are laid ... along the outer
surface of the inner layer. Deflection wires are then fed into the wire
lumens." Id. ,r 8. "A pressurized fluid is injected into each wire lumen to
maintain the internal diameter of each wire lumen at a diameter that is
greater than the diameter of the deflection wire" when heat is applied to melt
an outer polymer layer. Id.
Claims 36-55 are on appeal. Claim 36 is illustrative and reads as
follows ( emphasis added):
36. An apparatus comprising:
a flexible tubular body having a distal region and a proximal region,
each of the distal region and the proximal region including an outer layer, an
inner layer, at least two wire lumens, and a central lumen sized to receive a
catheter or sheath, wherein the central lumen is defined by an inner surface
oftheinnerlayer; and
at least two deflection wires,
wherein each of the at least two wire lumens is defined by a respective
one of a plurality of spaghetti tubes equidistantly placed about a
circumference of an outer surface of the inner layer, the plurality of spaghetti
tubes being positioned within at least a portion of the outer layer,
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Appeal2018-004890
Application 13/625,053
wherein each of the at least two deflection wires is placed in a
respective one of the at least two wire lmnens, the at least two wire lmnens
each having an inner diameter that exceeds the outer diameter of its
respective deflection wire,
wherein each of the at least two wire lumens further contains a
pressurized fluid, and
wherein each of the at least two deflection wires extends through the
flexible tubular body to a point in the distal region of the flexible tubular
body.
Claims 45 and 51, the other independent claims, also require two wire
lumens that each includes a pressurized fluid.
DISCUSSION
The Examiner has rejected claims 36 and 38-55 under 35 U.S.C.
§ I03(a) as obvious based on Gardeski, 2 Taylor, 3 and Giaro. 4 Final Action5
3. The Examiner has rejected claim 37 under 35 U.S.C. § I03(a) as obvious
based on Gardeski, Taylor, Giaro, and Jansen. 6 Final Action 9. The same
issue is dispositive for both rejections.
The Examiner finds that Gardeski and Taylor would have made
obvious all of the limitations of the independent claims except for wire
lumens containing a pressurized fluid. Final Action 3--4. The Examiner finds
that "Giaro teaches that it is well known in the art to inject pressurized fluid
into an analogous lumen of a sheath to expand the sheath to the proper size
during manufacture (Col.2: 48-70)." Id. at 4. The Examiner concludes that it
2 US 2004/0116848 Al, pub. June 17, 2004.
3 US 5,676,653, iss. Oct. 14, 1997.
4 US 3,293,351, iss. Dec. 20, 1966.
5 Office Action mailed Oct. 5, 2017.
6 US 6,368,316 Bl, iss. April 9, 2002.
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Appeal2018-004890
Application 13/625,053
would have been obvious to "modify the at least two wire lumens of
Gardeski in view of Taylor by injecting a pressurized fluid into the lumen as
taught by Giaro to effectively enable the at least two wire lumens to be
properly expanded to the proper size such as for the placement of the
deflection wires in each respective wire lumen." Id.
Appellants argue that "Giaro is not from the same field of endeavor as
the claimed invention .... Nor is Giaro reasonably pertinent to the problem
faced by the inventor." Appeal Br. 10-11. Appellants argue that "[b ]ecause
Giaro is not analogous art, it cannot be combined with Gardeski, Taylor, or
any other reference in rejecting the instant claims under § 103 ." Id. at 11.
We agree with Appellants the Examiner has not shown prima facie
obviousness for the claims. Claim 3 6 is directed to an apparatus comprising
a flexible tubular body having "a central lumen sized to receive a catheter or
sheath," and at least two deflection wires that are each in a wire lumen that
contains a pressurized fluid. The Specification explains that the "invention
relates to the flexible tubular bodies of steerable catheters or sheaths." Spec.
Similarly, Gardeski "relates generally to elongated medical devices
adapted to be inserted through an access pathway into a body vessel, organ
or cavity ... and particularly to a catheter, e.g., a multi-lumen steerable
catheter." Gardeski ,r 1. Taylor "relates to a steerable catheter assembly and,
more particularly, to such a catheter assembly which is kink-resistant."
Taylor 1:13-15.
Giaro, on the other hand, "relates to electric power cables consisting
of one or more conductors insulated with a dielectric which comprises a
fluid, for example, paper impregnated with cable compound, an
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Appeal2018-004890
Application 13/625,053
impermeable sheath and an external armouring." Giaro 1:9-13. Giaro
explains that,
[i]n order to increase the voltage rating of an electric power
cable it is known to place the dielectric under a preliminary
pressure. When current passes through the cable the cable core
expands .... If the dielectric is placed under preliminary
pressure it is usual to provide reservoirs of fluid which will
maintain an increased pressure during the heating due to
passage of current.
Id. at 1:14--24. The Examiner cites Giaro's disclosure at column 2, lines 48
to 70, which reads (in relevant part) as follows:
Any cable being considered for application of the present
invention is subjected to two kinds of expansion, one obtained
by the initial injection of impregnating fluid, which determines
the initial pressure, for example at -20° C. ( dependent upon the
conditions of the terrain in which the cable is laid) and a
thermal expansion due to the heating of the cable by the electric
current when in working condition. The presence of these two
types of expansion makes it possible to obtain the cycle of the
expansion of the cable and its return to initial volume in such a
way that the sum of elastic energy offered by the two
movements may be a minimum and consequently the total
thickness of the armouring may also be a minimum.
Giaro 2 :48---61.
"Although§ 103 does not, by its terms, define the 'art to which [the]
subject matter [ sought to be patented] pertains,' this determination is
frequently couched in terms of whether the art is analogous or not, i.e.,
whether the art is 'too remote to be treated as prior art."' In re Clay, 966
F.2d 656, 658 (Fed. Cir. 1992) (quoting 35 U.S.C. § 103 and In re Sovish,
769 F.2d 738, 741 (Fed. Cir. 1985), alterations in original).
Two criteria have evolved for determining whether prior art is
analogous: (1) whether the art is from the same field of
endeavor, regardless of the problem addressed, and (2) if the
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Application 13/625,053
reference is not within the field of the inventor's endeavor,
whether the reference still is reasonably pertinent to the
particular problem with which the inventor is involved.
Id. at 658-59.
We agree with Appellants that Giaro does not meet either of the tests
for analogous prior art. Giaro is not from the same field as the inventor's
endeavor because Giaro relates to electric power cables that are laid in
"terrain" while the claimed invention (like the devices of both Gardeski and
Taylor) relates to a steerable catheter for insertion into the body of a patient.
And Giaro is not reasonably pertinent to the problem with which
Appellants are involved. The Specification explains that prior art methods
created flexible tubular bodies for steerable catheters in which the "deflection
wires and the resulting wire lumens end up being approximately equal in
diameter. This creates three related difficulties." Spec. ,r 4. The problem
solved by the claimed apparatus is the "need in the art for a less expensive
method of manufacturing a flexible tubular body with deflection wires that
generate less deflection wire actuation friction and are less likely to lock
when the body is being deflected." Id. ,r 7. Gardeski and Taylor are similarly
directed to improvements in steerable catheters. Gardeski ,r,r 18-19, Taylor
2:13-37.
Giaro' s invention, by contrast, is directed to the problem of
"maintain[ing] the required pressure" on a "dielectric which comprises a
fluid, for example, paper impregnated with cable compound" in an electric
power cable. Giaro 1:9-12, 26-29. See also id. at 1 :42--45 ("A further object
of the present invention is to provide an elastic armouring consisting of a
material, such as steel, which is capable of exerting a very high pressure on
the cable core."); 2: 10-15 ("to provide an elastic armouring of metal laid
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Appeal2018-004890
Application 13/625,053
helically over the cable ... for even the highest internal pressures used and
can operate to exercise the necessary pressure over the greatest variation.").
Giaro's invention thus is directed to solving a different problem, in a
different field, from the invention claimed by Appellants and the inventions
disclosed by Gardeski and Taylor.
Because Giaro is nonanalogous art with respect to the claimed
invention, we conclude that the Examiner has not persuasively shown that a
person of ordinary skill in the art would have considered it obvious to
modify the device made obvious by Gardeski and Taylor to include wire
lumens containing a pressurized fluid, as claimed. We therefore reverse the
rejection of claims 36 and 38-55 under 35 U.S.C. § I03(a) based on
Gardeski, Taylor, and Giaro, and the rejection of claim 37 under 35 U.S.C.
§ I03(a) based on Gardeski, Taylor, Giaro, and Jansen.
REVERSED
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