Ex Parte Golijanin

Patent Trial and Appeal Board

Mar 27, 2018

11515419 (P.T.A.B. Mar. 27, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111515,419 0910112006 Dragan Golijanin
136579 7590 03/29/2018
Novadaq Technologies ULC
c/o Morrison & Foerster LLP
755 Page Mill Road
Palo Alto, CA 94304-1018
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.
577672001001 5579
EXAMINER
NGUYEN, HIEN NGOC
ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
03/29/2018 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):
EOfficeP A@mofo.com
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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
Appeal 2016-000552
Application 11/515,419 1
Technology Center 3700
Before JENNIFER D. BAHR, EDWARD A. BROWN, and
ANTHONY KNIGHT, Administrative Patent Judges.
BROWN, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Dragan Golijanin ("Appellant") appeals under 35 U.S.C. § 134(a)
from the Examiner's decision, as set forth in the Final Office Action dated
September 17, 2014 ("Final Act"), rejecting claims 1, 3, 8-10, 12-14, 17,
and 19-22. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellant identifies Novadaq Technologies Inc. as the real party in interest.
Appeal Br. 1.
Appeal 2016-000552
Application 11/515,419
CLAIMED SUBJECT MATTER
Claim 1, reproduced below, is representative of the claimed subject
matter:
1. A method of determining the location of a cavernous nerve
in a subject during a surgical operation, comprising:
a) between 1 hour and 30 hours prior to said surgical
operation, injecting indocyanine green (ICG) into a cavernous
body of a penis or a clitoris or an epidural space, wherein the ICG
is taken up by or proceeds along the path of said cavernous nerve;
b) exposing said cavernous nerve to illumination
comprising an excitation wavelength of ICG, thereby causing
said ICG in or along the nerve or portion thereof to fluoresce;
and
c) detecting the fluorescence of said ICG, thereby
determining the location of said nerve during said surgical
operation.
Appeal Br. A-1 (Claims App.).
REJECTION
Claims 1, 3, 8-10, 12-14, 17, and 19-22 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Heinrich (US 2003/0232016 Al, published
Dec. 18, 2003), Dail et al. (Multiple vasodilator pathways from the pelvic
plexus to the penis of the rat, 11 Intl. J. Impotence Res. 277-85 (1999)
(hereinafter "Dail")), Yarnall et al. (US 6,331,703 Bl, issued Dec. 18, 2001)
(hereinafter "Yarnall"), Levine (US 2004/0174495 Al, issued Sept. 9,
2004), Hochman (US 2003/0236458 Al, published Dec. 25, 2003), and
Goldenberg (US 2002/0146369 Al, published Oct. 10, 2002).
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Application 11/515,419
ANALYSIS
Claim 1 is directed to "a method of determining the location of a
cavernous nerve in a subject during a surgical operation," comprising, in
relevant part, "a) between 1 hour and 30 hours prior to said surgical
operation, injecting indocyanine green (!CG) into a cavernous body of a
penis or a clitoris or an epidural space, wherein the ICG is taken up by or
proceeds along the path of said cavernous nerve." Appeal Br. (Claims App.
A-1 (emphases added)). Appellant's position is that the applied combination
of references fails to disclose or suggest performing step (a) in order to
determine the location of a cavernous nerve during the surgical operation.
Id. at 5---6.
The Examiner finds that Heinrich discloses incising tissue to expose a
surgical site having a plurality of nerves, and injecting a fluorescent dye that
is absorbable by the nerves into the surgical site. Final Act. 2-3 (citing
Heinrich i-fi-13, 8, 25). The Examiner also finds that Heinrich does not
explicitly disclose injecting indocyanine green (ICG) dye into a cavernous
body of a penis, or injecting the dye between 1 hour and 30 hours prior to
the surgical procedure. Id. at 3. The Examiner addresses these omissions of
Heinrich by relying on Dail, Yarnall, Levine, Hochman, and Goldenberg.
Id. at 3--4. Particularly, the Examiner finds that Dail discloses injecting dye
into a cavernous body of a penis prior to a surgical operation. Id. at 3 (citing
Dail, p. 278, i1 4, Fig. 1 ). The Examiner finds that Yarnall discloses
injecting dye into the body prior to a surgical operation. Id. (citing Yarnall,
col. 19, 11. 55---65). The Examiner finds that Levine discloses using ICG
angiography for pre-surgery preparation. Id. (citing Levine i1 83). The
Examiner finds that Hochman discloses labeling/distinguishing neuronal
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Application 11/515,419
tissue using ICG. Id. (citing Hochman, Abstract, i-f 138). Lastly, the
Examiner finds that Goldenberg discloses injecting a dye/contrast agent
between 1 hour and 30 hours prior to a surgical procedure. Id. (citing
Goldenberg i-fi-143, 61, 66; claims 1--4).
Based on these findings, the Examiner reasons that it would have been
obvious to one of ordinary skill in the art to modify Heinrich's method to
inject ICG into a cavernous body of a penis, as taught by Dail, Yarnall, and
Levine, because ICG is a commonly-used dye that enables surgeons to easily
identify the object of interest and plan or prepare before a surgery to
minimize incision mistakes and prevent damaging good tissue during the
surgery. Id. at 3--4. The Examiner concludes that Yarnall, Levine,
Hochman, and Goldenberg provide motivation for injecting ICG 1 hour to
30 hours prior to surgery and are only relied on to explicitly teach these
commonly known limitations in the field. Id. at 4.
In contrast to the Examiner, Appellant contends that none of the
applied references teaches or suggests using ICG to determine the location
of a nerve, much less administering ICG between 1 hour and 30 hours before
a surgical procedure for this purpose. Appeal Br. 7; Reply Br. 2, 12. Thus,
Appellant contends, the applied combination of references would not have
rendered obvious injecting ICG into a cavernous body of a penis or a clitoris
or an epidural space between 1 hour and 30 hours prior to a surgical
operation to determine the location of the nerve during the surgical
operation, as required by claim 1. Appeal Br. 7.
Appellant contends that Heinrich teaches applying an indicator during
surgery. Id. (citing Heinrich i-f 25). We note the Examiner does not appear
to find explicitly that Heinrich discloses injecting the dye prior to a surgical
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Application 11/515,419
procedure, that is, any time prior to a surgical operation. See Final Act. 2-3.
Heinrich discloses locating and identifying nerves during a radical
prostatectomy. Heinrich i-f 3. Regarding the introduction of an indicator,
Heinrich states:
Initially, as seen in FIG. 1, the operating surgeon creates an
incision, either retropubically or perineally, in the patient that
exposes the prostate "P" and the bladder "B." Next, an indicator
is introduced to the region surrounding the nerves "N" that are in
the vicinity of prostate "P" and bladder "B" by the operating
surgeon.
Id. i-f 3 (emphasis added). Accordingly, Heinrich discloses an operating
surgeon injecting a dye in a region surrounding nerves in the vicinity of the
prostate and bladder. Id. i-f 25. We agree with Appellant that Heinrich
teaches applying an indicator during surgery, not prior to a surgical
operation. See Appeal Br. 7. Heinrich explains that "[ t ]he indicator is
allowed to accumulate or concentrate in the nerves "N" for a period of time"
to allow the indicator to be detected. Id. i-f 27. Accordingly, this
accumulation or concentration in the nerves would appear to occur during
the surgery. As such, the Examiner's proposed modification would not only
change the time at which the indicator is injected in Heinrich to the specific
claimed time period prior to a surgical operation, but, more generally, would
change the injection time from during surgery to prior to surgery.
As noted by Appellant, the Examiner applies only Levine and
Hochman in the rejection to teach the use of ICG. Reply Br. 2. Appellant
contends that Levine teaches administering ICG for use as a tracer in
angiography to detect and diagnose abnormalities and diseases in vascular
tissue, not nervous tissue, of the eye. Appeal Br. 8 (citing Levine i-fi-183,
168). Appellant explains that angiography is used to visualize blood vessels.
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Id. at 11. Appellant contends that Levine is silent with respect to a
timeframe for injecting ICG, and does not disclose using ICG angiography
as part of pre-surgery preparation. Id. at 8; Reply 4--5 (citing Levine i-f 83).
The Examiner indicates that Levine is only relied on to provide
evidence that using ICG dye for surgical preparation is a common practice in
the field. Final Act. 7. The Examiner states, "Levine discloses that an ICG
angiography may be used for the detection and diagnosis of abnormalities
and diseases of the vasculature of the eye and that these high-resolution ICG
angiography images are used in pre-surgery preparation." Ans. 9 (citing
Levine i-f 83 (emphasis added)). As such, the Examiner does not establish
that Levine teaches or suggests using ICG to determine the location of a
nerve. Additionally, although paragraph 83 of Levine mentions both
"indocyanine green angiography" and "pre-surgery preparation," we agree
with Appellant that this paragraph does not disclose specifically the use of
"indocyanine green angiography" in such "pre-surgery preparation."
Appellant contends that Hochman does not teach or suggest
administering ICG to label/distinguish nerves, but rather, teaches
administering ICG to distinguish between normal, active tissue and
dysfunctional or tumorous (cancerous) tissue of the central and peripheral
nervous systems, and locating the nerves by detecting intrinsic signals,
which do not require the use of a dye, e.g., ICG. Appeal Br. 9 (citing
Hochman i-fi-159, 131, 136, 138); Reply Br. 6. Appellant contends Hochman
does not teach or suggest administering ICG to determine the location of
nerve tissue, let alone injecting ICG during the claimed time period before
surgery. Appeal Br. 9; Reply Br. 5. In fact, Appellant contends, Hochman
does not teach or suggest that ICG would even be absorbed by nerve tissue
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and remain in the nerves for the claimed time period to allow detection of
the nerve tissue during a subsequent surgical procedure. Id.
The Examiner indicates that Hochman is only relied upon to disclose
administering ICG into the body to distinguish nerves. Final Act. 6; Ans. 8,
see also Ans. 9 (indicating that paragraph 13 8 of Hochman discloses
labeling/ distinguishing nerve neurons using I CG dye).
Appellant maintains that Hochman fails to teach or suggest
administering ICG to label/distinguish or locate nerve tissue, but teaches
administering ICG to determine the location of dysfunctional or cancerous
tissue of the central and peripheral nervous systems. Appeal Br. 8-9 (citing
Hochman i-fi-159, 131, 136, 138); Reply Br. 6. Appellant contends that
paragraph 13 8 of Hochman does not teach or suggest determining the
location of a nerve by injecting ICG. Reply Br. 5-7. Appellant's
contentions are persuasive.
Accordingly, we are persuaded that the Examiner has not established
that it would have been obvious to inject ICG specifically "into a cavernous
body of a penis or a clitoris or an epidural space" to determine the location
of a cavernous nerve, as required by claim 1.
Appellant also contends that Dail teaches injecting an altogether
different dye, fluorogold, into the penile crus, and detecting the dye at a
different timeframe than claimed; namely, seven days later in the nerves of
the dissected prostate gland. Appeal Br. 7 (citing Dail, pp. 278-79, Fig. 2).
The Examiner responds that Dail is not relied on to disclose ICG and
administering ICG into the body in the claimed time period. Ans. 7. Rather,
the Examiner explains, Dail is relied on to teach injecting fluorescent dye
into a cavernous body of a penis prior to a surgical operation. Id. The
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Application 11/515,419
Examiner submits that fluorogold and ICG are similar fluorescent dyes,
"serving the same purpose and could be used interchangeably," as disclosed
in Appellant's Specification. Id. at 8; see Spec. i-f 43 (describing that the dye
can be "fluoro-gold").
Regarding the Examiner's position that fluorogold and ICG "could be
used interchangeably" (Ans. 8), Appellant points out that the Examiner
improperly relies on Appellant's Specification to support this position
(Reply Br. 3). Appellant contends that the Examiner fails to identify any
teaching or suggestion in the applied references or elsewhere in the prior art
that would have provided one of ordinary skill in the art with the requisite
reason or rationale for replacing fluorogold dye, as taught by Dail, with ICG
to determine the location of a nerve, let alone that ICG could even be used
interchangeably to determine the location of a nerve in the same manner as
fluorogold dye. Id. We agree with this contention.
Although Appellant acknowledges that Heinrich, Dail, and Hochman
relate to determining the location of a nerve (Reply Br. 2), of these
references, the Examiner relies only on Hochman for teaching the use of
ICG. As discussed above, we are persuaded that the Examiner has not
established by a preponderance of the evidence that Hochman teaches
determining the location of a cavernous nerve by injecting ICG.
Appellant contends that Yarnall teaches a sentinel node biopsy
procedure that involves injecting a different dye (i.e., blue dye) as a tracer
during a different time frame than claimed (i.e., ten minutes before incision),
into different tissue (sentinel nodes), which are not part of the nervous
system. Appeal Br. 8 (citing Yarnall, col. 19, 11. 38---65). The Examiner
explains that Yarnall is only relied on to provide evidence that injecting
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Application 11/515,419
fluorescent dye prior to surgery is common practice in the field. Final Act.
7; Ans. 8. Accordingly, the Examiner does not rely on Yarnall to teach
determining the location of a cavernous nerve by injecting ICG.
Appellant contends that Goldenberg teaches injecting a labeled
antibody 6 to 48 hours before a procedure to allow the antibody to localize
to a lesion or tumor. Appeal Br. 10 (citing Goldenberg para. 61 ). Appellant
asserts that one of ordinary skill in the art would not have reasonably
expected that the timeframe for ICG to be absorbed by nerve tissue would be
even similar to the timeframe for an altogether different labeled antibody to
localize to an altogether different lesion or tumor. Id.
The Examiner responds that "it is common knowledge that it takes a
good amount of time for dye to move through the body and to be taken up
by tissue (nerve or any other type of tissue)" and, therefore, it would have
been obvious "to inject dye into the body some hours before the surgery to
allow the nerve to fully take up the dye in order to enable the surgeon to
identify the nerve." Ans. 11.
But even assuming "it takes a good amount of time for dye to move
through the body and to be taken up by tissue (nerve or any other type of
tissue)," we are persuaded that the Examiner has not provided sufficient
evidence and reasoning to demonstrate that one of ordinary skill in the art
would have modified the method of Heinrich to inject ICG into a cavernous
body of a penis or a clitoris or an epidural space in order to determine the
location of a cavernous nerve, let alone would have further modified
Heinrich to administer ICG at this location between 1 hour and 30 hours
before a surgical operation, instead of during an operation.
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For these reasons, we do not sustain the rejection of claim 1, or of
claims 3, 8-10, 12-14, 17, and 19-22 depending therefrom.
DECISION
We reverse the Examiner's decision to reject claims 1, 3, 8-10, 12-
14, 17, and 19-22.
REVERSED
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