Ex Parte Crane et al

Patent Trial and Appeal Board

Aug 30, 2016

10421270 (P.T.A.B. Aug. 30, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
10/421,270 04/23/2003
26868 7590
Hasse & Nesbitt LLC
8837 Chapel Square Drive
Suite C
CINCINNATI, OH 45249
08/30/2016
FIRST NAMED INVENTOR
Robert L. Crane
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.
IRI-008 (AFD 633) 4789
EXAMINER
REMALY, MARK DONALD
ART UNIT PAPER NUMBER
3777
MAILDATE DELIVERY MODE
08/30/2016 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 PATENT TRIAL AND APPEAL BOARD
Ex parte ROBERT L. CRANE
and DAVID M. CALLARD
Appeal2014-009392
Application 10/421,270
Technology Center 3700
Before JAMES P. CAL VE, GEORGE R. HOSKINS, and
FREDERICK C. LANEY, Administrative Patent Judges.
CAL VE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from the final rejection of
claims 7-22 under 35 U.S.C. § 103(a) as unpatentable over Culver (US
6,487,428 Bl, iss. Nov. 26, 2002), Kimble (US 2003/0018271 Al, pub. Jan.
23, 2003), and Karellas (US 2002/0172323 Al, pub. Nov. 21, 2002). See
Appeal Br. 5, 9. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
Appeal2014-009392
Application 10/421,270
CLAIMED SUBJECT MATTER
Claims 7 and 11 are independent. Claim 7 is reproduced below.
7. A method for real-time visualization and detection
of an extravasated or infiltrated fluid that is substantially
transparent to near infrared light in subdermal or intradermal
tissues of a body portion near or at a site of an intravascular
injection, comprising the steps of:
(a) providing a near infrared (NIR) light source
emitting light including NIR light in a wavelength range of
about 0.3 to about 1.0 microns;
(b) illuminating a portion of the body including the
intended site of an intravascular injection with the light emitted
from the NIR light source;
( c) filtering the NIR light reflected from or transmitted
through the body portion to enhance the signal-to-noise ratio;
( d) detecting the filtered NIR light from the body
portion using a detector sensitive to light in the wavelength
range of the light source;
( e) generating a first image of the body portion using
the detected light;
(f) injecting a fluid that is substantially transparent to
NIR light into a vasculature within the body portion;
(g) generating in real time at least one second image
of the body portion and the injected NIR-transparent fluid using
the detected light, wherein the injected NIR-transparent fluid
appears within the vasculature as a lighter region in the at least
one second image; and
(h) comparing the first image with the at least one
second image in real time to determine the appearance in the at
least one second image of a lighter region outside and near the
vasculature within the body portion as evidence of
extravasation or infiltration of the NIR-transparent fluid.
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Appeal2014-009392
Application 10/421,270
ANALYSIS
Claims 7-22 as unpatentable over Culver, Kimble, and Karellas
Appellants argue claims 7-22 as a group. Appeal Br. 10-16. We
select claim 7 as representative. 37 C.F.R. § 41.37(c)(l)(iv). Claims 8-22
stand or fall with claim 7.
The Examiner found that Culver teaches substantially the method of
claim 7, including a spectral range that overlaps the claimed range and an
injected fluid (water) that is substantially transparent to the emitted light in
the spectral window, but does not teach the use of near-infrared (NIR) for
imaging. Final Act. 3.
The Examiner found that Kimble teaches a method of visualization of
veins with a NIR light source in the range of 650 nm to 1100 nm to locate a
vein for the insertion of an intravenous needle for blood transfusions or
injections of medication. Id. at 3--4. The Examiner determined that it would
have been obvious to combine the optical comparison means of Culver with
the imaging method of Kimble to identify and display extravasation portions
and to track the insertion and extraction of fluids such as contrast agents that
are injected into blood vessels during a medical procedure. Id. at 5.
The Examiner found that Culver and Kimble do not teach generating a
first image and an additional image and comparing the first, baseline image
with the additional image, but Karellas teaches this feature. Id. at 4--5. The
Examiner determined that it would have been obvious to include these steps
in the method of Culver and Kimble to produce a control image prior to
administering a stimulus or injection and subsequent images to compare
with the control image to detect extravasation, as Karellas teaches. Id.
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Appeal2014-009392
Application 10/421,270
Appellants argue that none of the references teach extravasation fluid
that is NIR-transparent, as claimed. Appeal Br. 13. Appellants particularly
argue that neither Culver nor Kimble teaches this feature and the Examiner
is making a prediction based on the alleged teaching of Culver of what might
be seen when employing the device of Kimble after injection water. Id. In
addition, Appellants argue that Kimble does not explicitly teach that "other
fluids appear transparent" and Figure 2 of Kimble illustrates blood vessels
rather than other fluids or structures being transparent. Reply Br. 3--4.
Appellants' arguments are not persuasive for several reasons. First,
the Examiner identified where Culver teaches injecting a fluid (water) that is
substantially transparent to light source 20 because the wavelength of light
source 20 is selected to minimize its absorption by water and hemoglobin.
Final Act. 3. Appellants' arguments that Culver and Kimble do not teach
this feature (Appeal Br. 13; Reply Br. 3--4) do not address or persuade us of
error in these findings. Culver teaches a method of detecting extravasation
of injected fluids that may include water and selecting wavelengths for the
radiated light 20 that minimizes its absorption by water and hemoglobin to
facilitate extravasation detection. Culver, 1:7-27, 4:15-19, 7:34--40, Fig. 6.
Second, the Examiner also determined that Culver's express teaching
of an embodiment in which extravasation detection uses wavelengths that
are absorbed by extravasation fluid and transparent to other fluids such as
water and hemoglobin would have led a skilled artisan reasonably to expect
success using another wavelength that favors absorption by hemoglobin, but
is transparent to extravasation fluid. Ans. 3--4. Kimble teaches selection of
NIR wavelengths that are absorbed by hemoglobin-containing structures
while passing through human skin. Kimble i-fi-12, 55.
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Appeal2014-009392
Application 10/421,270
Appellants' arguments do not persuade us of error in that finding or
determination of the Examiner. See In re Jung, 637 F.3d 1356, 1365 (Fed.
Cir. 2011) (approving of Board's practice, as set forth in Ex Parte Frye, of
requiring applicants to identify error in an Examiner's rejections); Ex Parte
Frye, Appeal 2009-006013, 2010 WL 889747, at *4 (BPAI Feb. 26, 2010)
(precedential) (a panel reviews rejections for error based on issues identified
by an appellant, in light of the arguments and evidence produced thereon).
Indeed, Appellants do not address this determination. See Reply Br. 2-5
(omitting discussion of Section 2 of the Answer where the Examiner made
these findings and determination).
The Examiner's determination responded to Appellants' argument
that the Examiner did not explain why the combination would have been
predictable for visualizing extravasation fluid, particularly a NIR-transparent
fluid. Appeal Br. 14. Culver teaches the detection of extravasation fluids as
discussed above. Culver and Kimble teach the selection of spectral ranges
that overlap the claimed NIR range and that can be absorbed or scattered by
vasculature and tissue of interest while passing through other tissue and
fluids, as desired. The Examiner reasonably determined that a skilled artisan
who was aware of these teachings would have been able to choose a light
source with a wavelength that favors absorption by hemoglobin while being
transparent to extravasation fluid. 1 See Ans. 3--4.
1 Appellants' explanation of the "halo effect" (Appeal Br. 13) does not
appear in their Specification (see Spec. 8:1-10:2). It is not clear how a fluid
that is "transparent" to NIR light (e.g., does not absorb, scatter, or interact
with NIR light) can create a "lighter region 23" in Figure 2b that obscures a
portion of vein 21 when the rest of vein 21 is detected by NIR light because
blood attenuates the NIR light. Spec. 9:7-10:2. This issue does not impact
on our decision as set forth above, however.
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Appeal2014-009392
Application 10/421,270
The remainder of Appellants' arguments have been considered but are
not persuasive. They do not impact on our analysis as set forth above nor do
they apprise us of Examiner error. Appellants' general discussion of prior
art references (Appeal Br. 10-13) does not apprise us of Examiner error and
thus is not persuasive. For example, Appellants' argument that Kimble does
not disclose detecting a body portion other than the vein or extravasation of
fluid is not persuasive where the Examiner has relied on Culver to teach this
claimed feature and Kimble to teach the visualization of such detection as
images. See Appeal Br. 12; Final Act. 3--4.
DECISION
We AFFIRM the rejections of claims 7-22.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRivIED
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