Ex Parte Weiss

Patent Trial and Appeal Board

Jul 7, 2017

14125737 (P.T.A.B. Jul. 7, 2017)

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.
14/125,737 12/12/2013 Steffen Weiss 2011P00640WOUS 9970
24737 7590 07/11/2017
PTTTT TPS TNTFT T FfTTTAT PROPFRTY fr STANDARDS
EXAMINER
465 Columbus Avenue HINDENBURG, MAX F
Suite 340
Valhalla, NY 10595 ART UNIT PAPER NUMBER
3736
NOTIFICATION DATE DELIVERY MODE
07/11/2017 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):
marianne. fox @ philips, com
debbie.henn @philips .com
patti. demichele @ Philips, com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEFFEN WEISS
Appeal 2016-003579
Application 14/125,737
Technology Center 3700
Before JEFFREY N. FREDMAN, JOHN G. NEW, and
RICHARD J. SMITH, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a
guidewire. The Examiner rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.
Statement of the Case
Background
“[T]he invention relates to guidewires for guiding a catheter or used
stand-alone for in-body sensing, in particular to guidewires that are suitable
to be guided using magnetic resonance imaging” (Spec. 1:2-4).
1 Appellant identifies the Real Party in Interest as Koninklijke Philips, N.V.,
(see App. Br. 3).
Appeal 2016-003579
Application 14/125,737
The Claims
Claims 1—15 are on appeal. Claim 1 is representative and reads as
follows:
1. A guide wire comprising:
a composite shaft comprising: a shaft region comprising
a first matrix material having a first flexibility; and a distal tip
region comprising a second matrix material having a second
flexibility, wherein the composite shaft is tapered in the distal
tip region;
one or more cables aligned with a length of the shaft
region, wherein the cables extend at least partially into the
distal tip region; and
a sensor provided in the distal tip region and connected to
the one or more cables.
The issues
A. The Examiner rejected claims 1, 2, 6—10, and 12 under 35 U.S.C.
§ 103(a) as obvious over Esch2 (Final Act. 2).
B. The Examiner rejected claims 3—5 under 35 U.S.C. § 103(a) as
obvious over Esch and Belef3 (Final Act. 2).
C. The Examiner rejected claim 11 under 35 U.S.C. § 103(a) as obvious
over Esch and Goodin4 (Final Act. 3).
D. The Examiner rejected claims 13—15 under 35 U.S.C. § 103(a) as
obvious over Esch and Rafiee5 (Final Act. 3).
2 Esch, B., US 5,701,905, issued Dec. 30, 1997.
3 Belef et al., US 6,475,226 Bl, issued Nov. 5, 2002.
4 Goodin et al., US 4,928,693, issued May 29, 1990.
5 Rafiee et al., US 7,682,352 B2, issued Mar. 23, 2010.
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Appeal 2016-003579
Application 14/125,737
A. 35 U.S.C. § 103(a) over Esch
The Examiner finds Esch teaches:
a guidewire as claimed by applicant including a composite shaft
comprising a shaft region 12 of a first matrix material of a first
flexibility and a distal tip region 18 of a matrix material
comprising a more flexible second flexibility and tapered as
shown at the arrow at 14 in figure 2, see col. 4 lines 5-15. The
softer, lower durometer matrix material of the region 18 is more
flexible than the stainless steel or carbon fiber added shaft
region 12. Esch also teaches a sensor 20 provided next to the
distal tip region with cables 24a,b either in the shaft or attached
to the shaft. It would have been obvious to one of ordinary skill
in the art to place actually place the sensor 20 in the distal tip
region 18 rather than next to the distal tip to measure either
pressure or temperature at the very distal tip of the guidewire.
The cables 24a,b would then extend into the distal tip to the
sensor. The method of manufacturing the guidewire would be
met by putting the above elements together to form the
guidewire.
(Final Act. 2).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Esch renders claim 1 obvious?
Findings of Fact
1. Esch teaches an
a guide catheter suitable for insertion into the vasculature of a
patient, having an outer wall, and an inner luminal surface
defined therein adapted for insertion of an interactive catheter,
wherein at least one sensing element, usually a pressure sensing
element but optionally a temperature or other sensing element,
is provided in the wall, preferably adjacent a distal end of the
guide catheter. . . . Preferably, the guide catheter is adapted for
positioning of the sensor near or adjacent a coronary ostium,
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Appeal 2016-003579
Application 14/125,737
e.g., it will have a shaped distal end which conforms to the
vasculature in the region of the ostia.
(Esch 2:55-66).
2. Figure 2 of Esch is reproduced below:
Figure 2 depicts
a preferred embodiment of a guide catheter with a built-in
transducer [that] comprises a tubular body 12 . . . The material
of the tubular-body 12 has a degree of flexibility, and may
incorporate a braid of thin stainless steel wire or carbon fiber to
increase its axial stiffness, pushability and resistance to kinking
... A short portion of softer, low durometer, material smoothly
curved into an atraumatic tip 18 is attached, for example, by
heat bonding.
(Esch 3:66 to 4:15).
3. Esch teaches
the sensor is positioned relatively close to the distal end 14 of
the tubular body 12, typically within 5 cm, so the measured
pressure will be the true ‘static’ pressure of blood from the left
ventricle of the heart during the cardiac cycle. This implies the
surface 22 of pressure sensor 20, should preferably face away
from the aortic valve exit.
(Esch 4:46-52).
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Appeal 2016-003579
Application 14/125,737
4. Esch teaches “the sensor 20 is located at a position on the guide
catheter 10 in relation to the curvature of the catheter at which arterial
contact is highly unlikely” (Esch 5:3—5).
5. Esch teaches “it is preferable to ensure that the sensor will not
come into direct contact with an artery wall, as this may lead to inaccurate
readings” (Esch 4:65—67).
6. Esch teaches:
Signal leads 24a, 24b carry electrical signals to and from the
transducer 20 to circuitry located outside the body . . . The
wires 24a, 24b for transmission of the signal may be embedded
within the catheter wall, for example by heat-bonding the wires
into a pre-formed catheter tube, or by extruding the catheter
shaft with the wires in place.
(Esch 5:21-35).
Principles of Law
A prima facie case for obviousness “requires a suggestion of all
limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) and “a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
Analysis
Appellant contended “the Office has not provided a specific finding of
fact supporting its implicit contention that it was known in the prior art to
‘measure either pressure or temperature at the very distal tip of the
guidewire’” (App. Br. 9).
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Appeal 2016-003579
Application 14/125,737
The Examiner responded that:
[I]t is the examiner[’]s contention it would have been
obvious to one of ordinary skill in the art to place the sensor
20 in the distal tip region 18 of Esch to measure either
pressure or temperature at the very distal end of the
guidewire rather than just short of the very distal end of the
guidewire. This would allow measurement of pressure or
temperature where tip 18 contacts the inner heart.
(Ans. 4).
In response, Appellants contended
Esch discloses that “it is preferable to ensure that the sensor
will not come into direct contact with an artery wall, as this
may lead to inaccurate readings” (see Esch col. 4, lines 65-67)
(emphasis added). Thus, the modification of Esch’s catheter
proposed by the Examiner’s Answer, in which the sensor is
moved to the tip of the catheter, renders Esch’s sensor
unsatisfactory for its intended purpose of providing accurate
readings.
(Reply Br. 5).
We find that Appellant has the better position. We note that claim 1
requires a distal tip region with a second matrix material and requires the
sensor to be in the distal tip region. Thus, Figure 2 of Esch depicts a distally
placed sensor, but the sensor is not within a distal tip region as required by
claim 1 because only region 18 is composed of a second matrix material
(where matrix material is broadly interpreted as any material which can
serve as a matrix for embedding a sensor) and the sensor is not in region 18
(FF 2).
Although Esch suggests positioning the sensor “close to the distal end
14” (FF 3), the Examiner does not identify either a teaching in Esch or a
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Appeal 2016-003579
Application 14/125,737
reason to place the sensor within the atraumatic tip 18 region of the guide
catheter. As Appellant points out, Esch does, however, teach avoiding direct
contact between the sensor and arterial wall contact (FF 4—5). Thus, the
evidence of record suggests that there are reasons to avoid placing the sensor
within the distal atraumatic tip but no countervailing reasons to choose to
place the sensor within the distal atraumatic tip.
Even if the Examiner relied upon generic “obvious equivalents” or
“changes in location” rationales, the specific teaching in Esch that the
locations are not equivalent, because direct contact of the sensor is not
preferred (FF 4—5), would still overcome these rationales. The Examiner
lacks a reference or other evidence teaching or suggesting a reason to place
the sensor within the distal tip region in the atraumatic tip second matrix
material as required by claim 1.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Esch renders claim 1 obvious.
B-D. 35 U.S.C. § 103(a)
These rejections rely upon the underlying obviousness rejection over
Esch. Having reversed the rejection of claim 1, we also necessarily reverse
these obviousness rejections because none of the additionally cited prior art
is relied upon to teach “a sensor provided in the distal tip region” with the
“distal tip region comprising a second matrix material” as required by claim
1.
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Appeal 2016-003579
Application 14/125,737
SUMMARY
In summary, we reverse the rejection of claims 1, 2, 6—10, and 12
under 35 U.S.C. § 103(a) as obvious over Esch.
We reverse the rejection of claims 3—5 under 35 U.S.C. § 103(a) as
obvious over Esch and Belef.
We reverse the rejection of claim 11 under 35 U.S.C. § 103(a) as
obvious over Esch and Goodin.
We reverse the rejection of claims 13—15 under 35 U.S.C. § 103(a) as
obvious over Esch and Rafiee.
REVERSED
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