Ex Parte Maschke

Patent Trial and Appeal Board

Jan 26, 2015

11583447 (P.T.A.B. Jan. 26, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte MICHAEL MASCHKE1
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Appeal 2012-005489
Application 11/583,447
Technology Center 3700
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Before ERIC B. GRIMES, ULRIKE W. JENKS, and CHRISTOPHER G.
PAULRAJ, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
cryocatheter, which have been rejected as obvious. We have jurisdiction
under 35 U.S.C. § 6(b).
We reverse.

1 According to Appellant, the Real Party in Interest is Siemens
Aktiengesellschaft (Appeal Br. 1).
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Application 11/583,447

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STATEMENT OF THE CASE
The Specification states that a known procedure uses liquid nitrogen
as a combination of balloon-expansion medium and cooling medium to
reduce restenosis in blood vessels (Spec. 4, ¶ 11). However, “it is a
disadvantage that the known procedure is multiply invasive, i.e. several
different catheters must be introduced – for preliminary investigation and for
treatment – one after another” (id. at 4, ¶ 12). The Specification discloses a
cryocatheter provided with an expandable balloon and an integral image
capture device so that diagnosis of a stenosis, as well as cryotherapy and
widening of the vessel, can take place in a single operation (id. at 5, ¶ 15).
Claims 29–31, 34, and 37–44 are on appeal. Claim 29 is the only
independent claim and reads as follows (emphasis added):
29. A cryocatheter that inserts into a vessel of a patient in a medical
procedure, comprising:
a catheter sheath;
a catheter inner side surrounded by the catheter sheath;
a catheter tip arranged at a distal end of the cryocatheter;
a feed line arranged in the catheter sheath that feeds an expansion and
cooling agent;
a balloon arranged near the catheter tip that is expanded by the
expansion and cooling agent;
an imaging sensor located near the catheter tip; and
an image capture device comprising the imaging sensor that maps a
region of the vessel around the balloon;
wherein a stent that is to be implanted in the vessel is arranged on an
outside of the balloon, said stent comprising a metallic wire mesh configured
to be uniformly stretched beyond an elastic limit upon the expansion of the
balloon, so to retain a stretched shape against the vessel; said stent
configured to retain said stretched shape subsequent to the balloon having
been collapsed, based on the expansion and cooling agent being drained
from the balloon;
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Application 11/583,447

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wherein the image capture device comprises an IVMRI (intravascular
magnetic resonance imaging) sensor and an IVUS (intravascular ultrasonic)
sensor or an OCT (optical coherence tomography) sensor and an IVUS
(intravascular ultrasonic) sensor that are rotated by a drive shaft;
and wherein the catheter sheath comprises a window in a region of the
imaging sensor that is transparent to an imaging method used by the imaging
sensor, and wherein said balloon and said stent are comprised of a material
that is transparent to the imaging method used by the imaging sensor.

The claims stand rejected under 35 U.S.C. § 103(a) as follows:
Claims 29–31 and 37 based on Gaterud,2 Lalonde,3 Klingensmith,4
Crowley,5 Barrett,6 and Roth7 (Ans. 5);
Claim 38 based on Gaterud, Lalonde, Klingensmith, Crowley, Barrett,
Roth, and McAlister8 (Ans. 7);
Claims 39–41 based on Gaterud, Lalonde, Klingensmith, Crowley,
Barrett, Roth, and Haim9 (Ans. 8);
Claim 42 based on Gaterud, Lalonde, Klingensmith, Crowley, Barrett,
Roth, Haim, Ben-Haim,10 and Carroll11 (Ans. 8);
Claim 43 based on based on Gaterud, Lalonde, Klingensmith,
Crowley, Barrett, Roth, and Tartacower12 (Ans. 9); and

2 Gaterud et al., US 5,522,882, issued June 4, 1996.
3 Lalonde et al., US 6,283,959 B1, issued Sept. 4, 2001.
4 Klingensmith et al., US 2004/0037455 A1, published Feb. 26, 2004.
5 Crowley, US 5,544,660, issued Aug. 13, 1996.
6 Barrett, US 4,684,370, issued Aug. 4, 1987.
7 Roth, US 5,209,725, issued May 11, 1993.
8 McAlister et al., US 5,599,324, issued Feb. 4, 1997.
9 Haim et al., US 6,309,370 B1, issued Oct. 30, 2001.
10 Ben-Haim, US 6,203,493 B1, issued Mar. 20, 2001.
11 Carroll et al., US 6,471,693 B1, issued Oct. 29, 2002.
12 Tartacower et al., US 5,606,981, issued Mar. 4, 1997.
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Claim 44 based on Gaterud, Lalonde, Klingensmith, Crowley, Barrett,
Roth, and Bek13 (Ans. 10).
DISCUSSION
The Examiner has rejected independent claim 29 as obvious based on
Gaterud, Lalonde, Klingensmith, Crowley, Barrett, and Roth (Ans. 5). The
Examiner has rejected all of the dependent claims as obvious based on the
same references, by themselves or combined with additional prior art (id. at
5–10). The same issue is dispositive for all of the rejections.
The Examiner finds that the cited references disclose each of the
limitations of claim 29 (id. at 5–6). In particular, the Examiner finds that
“Klingensmith discloses [ ] providing an IVUS device in combination with
an OCT device to obtain images of a patient’s vasculature. Klingensmith
also discloses that the imaging devices can be rotated [0024].” (Id. at 6.)
The Examiner also finds that “Crowley discloses a catheter comprising a
drive shaft 18, arranged within the sheath of the catheter, which rotates an
imaging sensor within the catheter and a window 24 that is transparent to the
imaging device” (id.).
The Examiner concludes that it would have been obvious to modify
Gaterud’s catheter by “providing an IVUS device in combination with an
OCT device, as taught by Klingensmith, providing a drive shaft and
window, as taught by Crowley, in order to enable rotation of the imaging
device within the catheter and the imaging of the area surrounding the
catheter and in order to increase the versatility of the device” (id. at 7).

13 Bek et al., US 6,733,495 B1, issued May 11, 2004.
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Appellant argues, among other things, that “[a]lthough [the cited]
portion of Klingensmith discloses that a ‘rotating transducer’ . . . may be
used to gather IVUS data, there is no mention of an OCT sensor that is
rotated by a drive shaft” (Appeal Br. 7), and none of the other cited
references discloses an OCT sensor and an IVUS sensor that are rotated by a
drive shaft (id.).
The Examiner responded to this argument as follows:
There is no disclosure in the Klingensmith reference that the
OCT device would be used any differently than the IVUS
device, one would expect that if the imagers of the device
would be provided in the configuration stated in the reference
and that if the different imager were meant to be operated
differently there would be a mention of such a fact in the
reference. As such, it can be inferred that the OCT device
would be operated in the same manner as the IVUS device and
that would include the OCT device being rotated to image the
object.
(Ans. 13.)
Appellant, however, argues that the Examiner “cannot rely on an
absence of documentary evidence (‘there is no disclosure in the
Klingensmith reference that the OCT device would be used any differently
than the IVUS device’) to substitute for documentary evidence” (Appeal Br.
8). Appellant also “traverses the [Examiner’s] assertion that ‘it can be
inferred that the OCT device would be operated in the same manner as the
IVUS device’ since it is not well known that an OCT device will be operated
in the same manner as an IVUS device of the same system” (id.).
We agree with Appellant that the Examiner has not pointed to
evidence of record to support a finding that an OCT sensor that is rotated, as
required by the claims on appeal, is disclosed by Klingensmith or would
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otherwise have been obvious to a person of ordinary skill in the art. The
Examiner cites Klingensmith’s disclosure that
IVUS data is typically gathered in segments, either through a
rotating transducer or an array of circumferentially positioned
transducers, where each segment represents an angular portion
of an IVUS image. Thus, it takes a plurality of segments (or a
set of IVUS data) to image an entire cross-section of a vascular
object. . . . It should be appreciated that the present invention is
not limited to the use of an IVUS device (or the acquisition of
IVUS data), and may further include using thermographic
devices, optical devices (e.g., an optical coherence tomography
(OCT) console), MRI devices, or any vascular imaging devices
generally known to those skilled in the art.
(Klingensmith 2, ¶ 24.)
This passage states that IVUS data is typically gathered using a
rotating transducer, but does not expressly state or otherwise suggest that an
OCT sensor, if included in Klingensmith’s invention, should also be
rotatable. The Examiner reasons that, based on the omission of details
concerning imaging devices other than an IVUS transducer, “it can be
inferred” that they would be operated in the same way as the IVUS device
(Ans. 13). The Examiner, however, provides no evidence or sound technical
reasoning to support such an inference. The Examiner has not, for example,
provided a reference describing a rotatable intravascular OCT sensor, or
explained why rotating an intravascular OCT sensor would be necessary in
the context of Klingensmith’s invention.
In summary, the Examiner’s finding that Klingensmith discloses an
OCT sensor that can be rotated is not supported by the evidence, and the
Examiner has not persuasively explained why it would nevertheless have
been obvious based on the cited references. Thus, the Examiner has not
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made a prima facie case that all of the limitations of the claimed cryocatheter
would have been obvious based on the teachings of Gaterud, Lalonde,
Klingensmith, Crowley, Barrett, and Roth, and the rejection of claims 29–31
and 37 on that basis is reversed. The other rejections on appeal rely on the
same flawed reasoning, and are reversed for the same reason.
SUMMARY
We reverse all of the rejections on appeal.

REVERSED

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