Ex Parte Kleen et al

Board of Patent Appeals and Interferences

Jun 20, 2012

11473412 (B.P.A.I. Jun. 20, 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.
11/473,412 06/23/2006 Martin Kleen 2005P03461US 7185
22116 7590 06/20/2012
SIEMENS CORPORATION
INTELLECTUAL PROPERTY DEPARTMENT
170 WOOD AVENUE SOUTH
ISELIN, NJ 08830
EXAMINER
MEHTA, PARIKHA SOLANKI
ART UNIT PAPER NUMBER
3737
MAIL DATE DELIVERY MODE
06/20/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MARTIN KLEEN, MARCUS PFISTER, and
THOMAS REDEL
__________

Appeal 2011-004921
Application 11/473,412
Technology Center 3700
__________

Before TONI R. SCHEINER, ERIC GRIMES, and ERICA A. FRANKLIN,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a medical
imaging method, which the Examiner has rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
“Optical Coherence Tomography (OCT) is an imaging method for
displaying up to 2 mm thick tissue structures with a resolution of
approximately 15 µm” (Spec. 1, ¶ 3). “Catheter-based OCT imaging is
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Application 11/473,412

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particularly revealing in the case of atherosclerotic narrowing of blood
vessels” (id. at 6, ¶ 23). In some atherosclerotic plaque, “fatty deposits
(lipid pool) form . . . with a thin fibrous shell between the lumen and lipid
pool, generally resulting in inflammation and thus causing the accumulation
of macrophages (engulfing cells). A plaque of this type which tends to
cause rupture . . . , is referred to as ‘vulnerable plaque.’” (Id.)
Claims 4 and 6-8 are on appeal. Claim 4 is representative and reads
as follows (with letter designations of each step added):
4. An imaging method using an optical coherence tomography (OCT)
catheter for visualizing a molecular functional process in a vulnerable plaque
of a blood vessel in a blood vessel system of a patient, comprising:
[a.] increasing morphological contrast of a vulnerable plaque in the
blood vessel with one contrast medium during both a non-invasive magnetic
resonance procedure and a catheter-based OCT imaging procedure by
injecting the one contrast medium comprising paramagnetic iron oxide
particles into the blood vessel system prior to performance of the non-
invasive magnetic resonance tomography procedure;
[b.] performing the non-invasive magnetic resonance tomography
procedure to identify a location of the vulnerable plaque using said contrast
medium;
[c.] inserting an OCT catheter having a light-emitting and light-
absorbing OCT catheter head into the blood vessel comprising the
vulnerable plaque, based on identification of a location of the vulnerable
plaque using the one contrast medium in conjunction with the non- invasive
procedure;
[d.] inflating at least one occlusion balloon associated with the
catheter and rinsing the blood vessel from blood with a rinsing fluid; and
[e.] generating an image of the vulnerable plaque marked by the
contrast medium by continuously controlling a movement of the catheter
head along the vulnerable plaque.

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Application 11/473,412

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Issue
The Examiner has rejected claims 4 and 6-8 under 35 U.S.C. § 103(a)
based on Tearney1 and Kooi2 (Answer 3). The Examiner finds that Tearney
teaches OCT imaging of vulnerable plaque in a blood vessel, and Kooi
teaches using a contrast agent and magnetic resonance imaging (MRI) to
locate vulnerable plaque in blood vessels (id. at 4). The Examiner concludes
that it would have been obvious “to have modified Tearney (‘622) to first
perform the contrast-enhanced MR method of Kooi (2003), in order to non-
invasively and accurately locate the plaque prior to commencing invasive
OCT analysis” (id.).
Appellants contend that the rejection “presupposes that there is
recognition in the prior art that one contrast medium exists which is suitable
for use in both a non-invasive magnetic resonance procedure and a catheter-
based OCT imaging procedure . . . [but] there is no basis to assume that the
one contrast medium would somehow be suitable for both MRI and OCT”
(Appeal Br. 5). Appellants also contend that “neither of the references
suggest performing OCT after MRI” (id. at 6).
The issue presented is: Does the evidence of record support the
Examiner’s conclusion that a method that includes all of the steps of claim 4
would have been obvious based on Tearney and Kooi?

1 Tearney et al., Patent Application Publication US 2006/058622 A1, Mar.
16, 2006.
2 Kooi et al., Accumulation of Ultrasmall Superparamagnetic Particles of
Iron Oxide in Human Atherosclerotic Plaques Can Be Detected by In vivo
Magnetic Resonance Imaging, 107 CIRCULATION 2453-2458 (2003).
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Findings of Fact
1. Tearney discloses that conventional imaging technologies,
including magnetic resonance imaging (MRI) are not able to reliably
identify the microscopic features that characterize vulnerable plaque
(Tearney 1, ¶ 5).
2. Tearney discloses that “it is believed that no method other than
optical coherence tomography (‘OCT’) has been shown to reliably identify
the characteristic features of these lesions” (id.).
3. Tearney discloses that “[s]trong attenuation of light in blood may
present a significant challenge for intravascular optical imaging methods”
(id. at 1, ¶ 7).
4. Tearney discloses that one solution to the interference of blood
with OCT imaging is “to completely occlude the artery, and replace blood
with saline. This technique that is commonly deployed in angioscopic
imaging requires proximal balloon occlusion. Following vascular occlusion,
all of the remaining blood in the vessel is replaced with saline.” (Id. at 1,
¶ 9.)
5. Kooi discloses that “[o]ne of the features of high-risk
atherosclerotic plaques is a preponderance of macrophages. Experimental
studies with hyperlipidemic rabbits have shown that ultrasmall super-
paramagnetic particles of iron oxide (USPIOs) accumulate in plaques with a
high macrophage content and that this induces magnetic resonance (MR)
signal changes.” (Kooi 2453.)
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6. Kooi discloses a “study . . . to investigate the feasibility of in vivo
MR imaging of USPIO accumulation in human atherosclerotic plaques”
(id.).
7. Kooi discloses that “the tested USPIOs accumulate predominantly
in macrophages in ruptured and rupture-prone human atherosclerotic lesions
and that this can induce significant signal changes in the . . . MR images
acquired 24 hours after intravenous administration of USPIOs” (id. at 2456).
8. Kooi concludes that “USPIO-enhanced MRI is a promising
noninvasive method to identify high-risk plaques” (id.).
9. The Specification states that “[f]or intravascular OCT imaging, the
OCT catheter inserted into the vessel . . . to be examined is slowly removed
in the form of a continuously controlled movement, while the laser light
scattered and/or reflected at the vessel inner wall is . . . analyzed and
processed in an imaging fashion” (Spec. 1, ¶ 4).
10. The Specification states that “[s]ince the examination with a non-
invasive method (e.g. MRT or US) always precedes an invasive OCT
examination, it would be advantageous in terms of supplementing both
examination methods to use a contrast medium which can be used equally
for both methods” (id. at 8, ¶ 29).
Analysis
Tearney teaches imaging of vulnerable plaques using optical
coherence tomography (OCT). With regard to the claimed steps of
[c.] inserting an OCT catheter having a light-emitting and light-
absorbing OCT catheter head into the blood vessel comprising
the vulnerable plaque . . . ;
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[d.] inflating at least one occlusion balloon associated with the
catheter and rinsing the blood vessel from blood with a rinsing
fluid; and
[e.] generating an image of the vulnerable plaque marked by the
contrast medium by continuously controlling a movement of
the catheter head along the vulnerable plaque
(claim 4), Tearney either expressly teaches these steps or the Specification
concedes that they are conventionally done in OCT imaging (see FFs 2-4, 9).
Kooi teaches the steps of
[a.] . . . injecting the one contrast medium comprising
paramagnetic iron oxide particles into the blood vessel system
prior to performance of the non-invasive magnetic resonance
tomography procedure; [and]
[b.] performing the non-invasive magnetic resonance
tomography procedure to identify a location of the vulnerable
plaque using said contrast medium.
(Claim 4.) See FFs 5-8.
We agree with the Examiner’s conclusion (Answer 4) that it would
have been obvious to follow-up Kooi’s method of using MRI to identify
vulnerable plaques with Tearney’s OCT method of imaging them because
Tearney teaches that the microscopic features that characterize vulnerable
plaque can only be reliably identified using OCT (FFs 1, 2). Thus, it would
have been obvious to use Tearney’s OCT method to confirm the presence of
vulnerable plaques identified using Kooi’s MRI method. This is especially
the case in light of the Specification’s concession that an invasive OCT
examination is always preceded by a noninvasive method such as magnetic
resonance tomography (MRT) (FF 10).
Appellants argue that the Examiner’s combination of references
requires “recognition in the prior art that one contrast medium exists which
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is suitable for use in both a non-invasive magnetic resonance procedure and
a catheter-based OCT imaging procedure” (Appeal Br. 5) but only the
Specification teaches “that SPIO particles can be used to enhance the
contrast of vulnerable plaque when imaged with an OCT technique” (id. at
6).
This argument is not persuasive. It is true that Tearney and Kooi do
not teach injecting contrast medium for the purpose of “increasing
morphological contrast . . . of both” MRI and OCT, as recited in claim 4.
However, Kooi discloses that ultrasmall superparamagnetic particles of iron
oxide (USPIOs) increase morphological contrast of vulnerable plaques in
MRI, and therefore provides a reason for injecting this contrast agent and
then performing MRI. Thus, the steps of the method that is made obvious
by the prior art are the same as the steps of the claimed method.
Whether Appellants combine the steps for a different reason than
would have been obvious based on the prior art, or whether Appellants have
discovered an additional advantage to carrying out the obvious process, does
not change the fact that Tearney and Kooi would have made obvious the
process that is defined by claim 4. See KSR Int’l Co. v. Teleflex Inc., 550
U.S. 398, 419-20 (2007) (“[N]either the particular motivation nor the
avowed purpose of the patentee controls. . . . [A]ny need or problem known
in the field of endeavor at the time of invention and addressed by the patent
can provide a reason for combining the elements in the manner claimed.”);
In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990) (“It is a general rule
that merely discovering and claiming a new benefit of an old process cannot
render the process again patentable.”).
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Appellants concede that “claims 6 and 8 stand or fall with claim 4”
(Appeal Br. 6). With regard to claim 7, Appellants argue that “claim 7 is
non-obvious because there is no recognition that a contrast medium used for
MRI might also have such optical properties that render the contrast medium
useful for OCT imaging as well” (Appeal Br. 7).
This argument is the same as that presented for claim 4, and is
unpersuasive for the same reason.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that a
method that includes all of the steps of claim 4 would have been obvious
based on Tearney and Kooi.
SUMMARY
We affirm the rejection of claims 4 and 6-8 as obvious in view of
Tearney and Kooi.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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