Ex Parte Golijanin et al

Patent Trial and Appeal Board

Mar 28, 2017

11851312 (P.T.A.B. Mar. 28, 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.
11/851,312 09/06/2007 Dragan Golijanin 577672000900 9069
136579 7590 03/30/2017
Novadaq Technologies Inc.
c/o Morrison & Foerster LLP
755 Page Mill Road
Palo Alto, CA 94304-1018
EXAMINER
JONES, DAMERON LEVEST
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
03/30/2017 ELECTRONIC
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DRAGAN GOLIJANIN,
LUKASZ BRZOZOWSKI, and RONALD WOOD1
Appeal 2015-005990
Application 11/851,312
Technology Center 1600
Before FRANCISCO C. PRATS, TAWEN CHANG, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a method of
localizing a lymph node draining a penile tumor. The Examiner rejected the
claims for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.
STATEMENT OF THE CASE
The sole rejection before us for review is the Examiner’s
rejection of claims 1—16 under 35 U.S.C. § 103(a) for obviousness
over Woltering.2 Ans. 3^4; Non-Final Action 2—A?
1 Appellants identify Novadaq Technologies Inc. as the real party in interest.
App. Br. 1.
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Application 11/851,312
Claims 1, 9, and 12 are representative and read as follows (App. Br.
A-l, A-2):
1. A method of localizing before or during a surgical
operation a lymph node draining a penile tumor having edges
and a base, in a subject, comprising:
a) 10 minutes to 24 hours prior to said surgical
operation, injecting the edges or the base of said tumor of said
subject with a dye which fluoresces at an emission wavelength
when said dye is contacted with an excitation wavelength;
b) exposing said lymph node before or during said
operation to illumination, the illumination comprises said
excitation wavelength and causes said fluorescent dye to
fluoresce; and,
c) detecting the fluorescence of said dye at said
lymph node.
9. A method of claim [1, wherein said dye is a
tricarbocyanine dye, and] wherein the tricarbocyanine dye is
indocyanine green.
12. A method of claim 1, wherein said dye is injected
between 1 hour and 6 hours before said surgical operation.
DISCUSSION
The Examiner’s Prima Facie Case
The Examiner’s position, essentially, is that Woltering teaches or
suggests a process having all of the features of claims 1—16. After reviewing
the relevant teachings in Woltering {see Ans. 2—3), the Examiner concludes
that claims 1—16 would have been obvious to an ordinary artisan, because
“both Appellant and Woltering disclose methods of localizing lymph node in
a subject having a penile tumor/cancer using a fluorescent dye wherein the
2 U.S. Patent No. 7,381,400 B2 (issued June 3, 2008).
3 Non-Final Rejection entered January 22, 2014.
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Application 11/851,312
dye may be administered] in a time frame of 10 minutes to 24 hours prior to
the surgical operation.” Id. at 3.
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
As the Supreme Court pointed out in KSR Int 7 Co. v. Teleflex
Inc., 550 U.S. 398 (2007), when determining whether the prior art supplied a
reason for practicing the claimed subject matter, the analysis “need not seek
out precise teachings directed to the specific subject matter of the challenged
claim, for a court can take account of the inferences and creative steps that a
person of ordinary skill in the art would employ.” Id. at 418; see also id. at
421 (“A person of ordinary skill is ... a person of ordinary creativity, not an
automaton.”).
Ultimately, therefore, “[i]n determining whether obviousness is
established by combining the teachings of the prior art, the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art.” In re GPACInc., 57 F.3d 1573, 1581 (Fed. Cir.
1995) (internal quotations omitted).
Appellants do not persuade us that a preponderance of the evidence
fails to support the Examiner’s prima facie case of obviousness as to either
claim 1 or claim 9. In particular, Appellants do not persuade us that the
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Examiner erred in finding that Woltering suggests the process recited in
Appellants’ claims 1 and 9.
As required by claim 1, Woltering discloses a process of localizing,
before or during a surgical operation, a lymph node draining a penile tumor.
See Woltering, abstract (describing a “procedure for sentinel lymph node
identification and biopsy”); see also id. at 6:1—8 (procedure can be used to
identify sentinel lymph node “of any solid tumor that is known to
metastasize, including . . . penile cancer”).
In Woltering’s process, a radiolabeled dye is mixed with an unlabeled
dye, which may be identical to the radiolabeled dye except for the label, the
unlabeled dye being present in a “sufficient amount to enhance visual
location of the lymph node(s).” Id. at 4:5—6.
As to claim 1 ’s first step of injecting the dye, as the Examiner found
(Ans. 2), Woltering discloses that the dye mixture “is injected at the time of
surgery, and rapidly migrates to reach the lymph nodes in less than 20 min,
more preferably in less than 15 min, and most preferably in less than 10
min.” Woltering, 4:8—11.
Although Woltering states that the dye mixture is injected “at the time
of surgery” (see id.), because the dye takes up to 20 minutes to migrate to
the lymph node (see id.), Appellants do not persuade us (see App. Br. 7—11;
Reply Br. 2—6) that the Examiner erred in finding that Woltering suggests
that the dye should be injected up to 20 minutes prior to the surgery that
visualizes the lymph node. Because injecting the dye mixture up to 20
minutes prior to the surgery is encompassed by the range in Appellants’
claim 1 of injecting 10 minutes to 24 hours before surgery, we discern no
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error in the Examiner’s finding that Woltering suggests injecting its dye at a
time encompassed by claim 1.
As required by claim 1, Woltering discloses that its dye may be any of
a number of dyes, including a “fluorescent dye, an ultraviolet fluorescent
dye, a visible fluorescent dye, and [an] infrared fluorescent dye . . .
Woltering, 4:58—59.
As to steps (b) and (c) of claim 1, exposing the lymph node to
illumination at a wavelength that causes fluorescence and thereby detecting
the lymph node, Woltering discloses that “the presence of the non-
radiolabeled dye in a tissue may be observed optically due to the non-
radiolabeled dye’s visible, ultraviolet, or infrared absorption, fluorescence,
luminescence, or phosphorescence.” Id. at 8:53—57 (emphasis added).
Given this teaching, Appellants do not persuade us (see App. Br. 9; Reply
Br. 4—5) that the Examiner erred in finding that Woltering suggests exposing
the lymph node to illumination at a wavelength that causes fluorescence and
thereby detecting the lymph node.
In sum, given the discussed teachings, we agree with the Examiner
that Woltering would have suggested performing a process having all of the
steps and features of Appellants’ claim 1. Accordingly, we find that a
preponderance of the evidence supports the Examiner’s prima facie case of
obviousness as to claim 1.
Appellants’ arguments do not persuade us to the contrary. It might be
true that the radioactive colloid discussed by Woltering in relation to the
prior art (see Woltering, 1:49-2:52) does not correspond to a fluorescently
visualized dye, as Appellants argue. See App. Br. 7—9; Reply Br. 3. That
fact does not, however, undercut Woltering’s express teachings, discussed
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above, of the desirability of using an optically visualized dye, which may be
a fluorescent dye, which has up to a 20 minute migration period.
As to Appellants’ contention that “Woltering neither contemplates nor
enables the localization of lymph nodes by injecting a fluorescent dye prior
to surgery” (Reply Br. 4), as noted above, Woltering expressly teaches
visualizing a dye using the dye’s “visible, ultraviolet, or infrared absorption,
fluorescence, luminescence, or phosphorescence.” Woltering, 8:55—57
(emphasis added). Appellants do not direct us to any specific persuasive
evidence suggesting that an ordinary artisan, armed with the knowledge in
the art, would have been unable to visualize a tumor, based on this teaching.
In sum, for the reasons discussed, Appellants do not persuade us that
the preponderance of the evidence fails to support the Examiner’s prima
facie case of obviousness as to claim 1. Because Appellants do not identify
any specific persuasive objective evidence of nonobviousness, we affirm the
Examiner’s rejection of claim 1 for obviousness over Woltering. Because
they were not argued separately, claims 2—8, 10, 11, and 13—16 fall with
claim 1. See 37 C.F.R. § 41.37(c)(l)(iv).
As to claim 9, as the Examiner found (Ans. 2), Woltering discloses
that “iodocyanine green” is among useful dyes. Woltering, 5:4. Appellants
do not dispute that Woltering’s iodocyanine green is the same dye as the
indocyanine green (ICG) recited in claim 9. As to Appellants’ argument that
iodocyanine green is part of a laundry list of useful dyes (Reply Br. 5), we
note that iodocyanine green is one of only about eight dyes expressly listed
in Woltering. See Woltering, 5:1—7. As to Appellants’ argument that
Woltering only exemplifies dyes that are visible to the naked eye (App. Br.
13—14), as noted above Woltering expressly teaches visualizing fluorescent
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dyes, including those that fluoresce under infrared or ultraviolet radiation
(see Woltering, 8:53—57), and Appellants have not identified any specific
persuasive evidence suggesting that an ordinary artisan, armed with the
knowledge in the art, would have been unable to fluorescently visualize a
tumor, based on that teaching.
In sum, because Appellants do not persuade us that the preponderance
of the evidence fails to support the Examiner’s prima facie case of
obviousness as to claim 9, and because Appellants do not advance specific
persuasive objective evidence of nonobviousness as to claim 9, we affirm
the Examiner’s rejection of claim 9 over Woltering.
As Appellants argue, however, claim 12 requires the dye to be
injected between 1 and 6 hours before the surgical operation. See App. Br.
11—12, see also id. at A-2 (claim 12). As noted above, Woltering teaches
using dyes that migrate to the lymph node of interest in at most 20 minutes.
See Woltering, 4:8—11. The Examiner does not specifically address claim
12, either in the presentation of the prima facie case or responding to
Appellants’ arguments.
Nor does the Examiner explain specifically why Woltering’s teaching
of using a dye with a migration period of at most 20 minutes would suggest
injecting the dye at the time period in relation to surgery required by claim
12. We note, as the Examiner argues (Ans. 10—11), that Woltering describes
an experiment establishing the migration time of methylene blue. See
Woltering 6:10-7:7. The Examiner does not explain adequately, however,
why that experiment would have suggested that, when performing a surgical
operation to localize a lymph node, an ordinary artisan would have failed to
follow Woltering’s express teaching of using a dye that migrates in 20
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minutes or less. Accordingly, because we agree with Appellants that the
Examiner did not explain sufficiently why an ordinary artisan would have
performed a process meeting all of the requirements of claim 12, we reverse
the Examiner’s rejection of that claim over Woltering.
SUMMARY
For the reasons discussed, we affirm the Examiner’s rejection of
claims 1—11 and 13—16 under 35 U.S.C. § 103(a) for obviousness over
Woltering.
For the reasons discussed, however, we reverse the Examiner’s
rejection of claim 12 under 35 U.S.C. § 103(a) for obviousness over
Woltering.
TIME PERIOD
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-IN-PART
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