Ex Parte Carroll et al

Patent Trial and Appeal Board

May 17, 2018

12776835 (P.T.A.B. May. 17, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/776,835 05/10/2010 Douglas R. Carroll
136579 7590 05/21/2018
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.
577672003400 3159
EXAMINER
PARK, PATRICIA JOO YOUNG
ART UNIT PAPER NUMBER
3737
NOTIFICATION DATE DELIVERY MODE
05/21/2018 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
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DOUGLAS R. CARROLL, ROBERT W. FLOWER, and
JOHN C. DOCHERTY
Appeal2016-002636 1
Application 12/776,835
Technology Center 3700
Before PHILIP J. HOFFMANN, BRADLEY B. BAY AT, and
AMEE A. SHAH, Administrative Patent Judges.
BAY AT, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner's
decision rejecting claims 1-20. We have jurisdiction over this appeal under
35 U.S.C. § 6(b). 2
We REVERSE.
1 The real party in interest is "Novadeq Technologies, Inc." Appeal Brief 1
("Appeal Br.," filed July 6, 2015).
2 Appellants waived hearing attendance on Feb. 15, 2018.
Appeal 2016-002636
Application 12/776,835
CLAIMED SUBJECT MATTER
Claims 1, 7, and 13 are the only independent claims on appeal.
Claim 1 is illustrative of the claimed subject matter, and reads as follows:
1. A method for enhancing endoscopic identification and
dissection of a blood vessel in tissue during endoscopic harvest,
comprising the steps of:
introducing an endoscope to a target region containing a
blood vessel to be harvested;
injecting ICG into the bloodstream;
illuminating the blood vessel in situ, via a multi-mode
light source, with excitation light capable of exciting
fluorescence in the ICG;
capturing, via a camera, fluorescence and color images of
the blood vessel in situ;
providing, via a processor, video signals to a display to
facilitate visualization of the blood vessel in situ;
locating the blood vessel to be harvested by observing the
ICG fluorescence; and
harvesting the located blood vessel for use in a
subsequent procedure.
Appeal Br. (Claims App.).
REJECTIONS
The following rejections are before us for review:
I. The Examiner rejected claims 1--4, 11-16, and 19 under
35 U.S.C. § 103(a) as being unpatentable over Taggart
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Application 12/776,835
("Preliminary Experience with a Novel Intraoperative
Fluorescence Imaging Technique to Evaluate the Patency of
Bypass Grafts in Total Arterial Revascularization," Ann Thorne
Surg (75):870-873 2003), Westwick (US 2008/0239070 Al,
pub. Oct. 2, 2008), and Duhaylongsod (US 2002/0038120 Al,
pub. Mar. 28, 2002).
II. The Examiner rejected claims 7, 9, 10, and 20 under 35 U.S.C.
§ I03(a) as being unpatentable over Hausen (US 2005/0182431
Al, pub. Aug. 18, 2005), Kaneko (US 2003/0187349 Al, pub.
Oct. 2, 2003), Westwick, and Taggart.
III. The Examiner rejected claims 5, 6, 17, and 18 under 35 U.S.C.
§ I03(a) as being unpatentable over Taggart, Westwick,
Duhaylongsod, and Kuipers ("Recirculatory and
Compartmental Pharmacokinetic Modeling of Alfentanil Pigs,"
Anesthesiology, 90: 1146-57, 1999).
IV. The Examiner rejected claim 8 under 35 U.S.C. § I03(a) as
being unpatentable over Taggart, Westwick, Duhaylongsod,
Kuipers, and Flower ("Injection technique for indocyanine
green and sodium fluorescein dye angiography of the eye,"
Investigative Ophthalmology, vol. 2 no. 12, pgs. 881-895,
1973).
Final Office Action 2-11 ("Final Act.," mailed Dec. 4, 2014); see also
Answer 2-11 ("Ans.," mailed Oct. 28, 2015).
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Application 12/776,835
ANALYSIS
Rejection I
independent claims 1 and 13
Appellants argue that the Examiner has failed to provide articulated
reasoning with some rational underpinning to support the obviousness
determination by establishing that a person of ordinary skill in the art would
have combined the teachings of Duhaylongsod with Taggart and W estwick,
as proposed, to arrive at the claimed invention. Appeal Br. 11-15; Reply
Brief 3-5 ("Reply Br.," filed Dec. 28, 2015). We agree.
In rejecting independent claims 1 and 13 3 as obvious over Taggart,
Westwick, and Duhaylongsod, the Examiner finds that "Taggart and
W estwick do not explicitly teach that imaging is directed for harvesting the
located blood vessel for use in a subsequent procedure." Final Act. 4;
Ans. 4. To cure this deficiency, the Examiner finds that "Duhaylongsod
teaches a method of identifying and manipulating vasculature under
transillumination imaging system ([0004] and [0027]), and explicitly teaches
introducing an endoscope to a target area containing a blood vessel to be
harvested ([0007], [0027] and [0040])." Final Act. 4; Ans. 4. The Examiner
asserts that one would "modify the method taught by Taggart and W estwick
to include the teachings of Duhaylongsod, as using [an] endoscope imaging
system in harvesting a [sic] graft vessels are well known in the art and
suitable for use in the method of open-chest coronary surgeries such as
Taggart." Final Act. 4; Ans. 4. The Examiner concludes, "[o ]ne of ordinary
3 "Regarding to [sic] claim 13, claim 13 is rejected in the same manner as
claim 1 above." Final Act. 5; Ans. 5.
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Application 12/776,835
skill in the art would have been motivated to make such a combination as it
provides simpler and facilitates location and extraction of the graft vessel
([0040])." Final Act. 5; Ans. 5.
Taggart's intraoperative fluorescence imaging technique is for
evaluating the patency of bypass grafts in total arterial revascularization.
Taggart 870. Because"[ e ]arly graft failure is a common cause of cardiac
morbidity and mortality after coronary artery bypass grafting (CABG),"
Taggart utilizes a SPY fluorescence imaging system to image each graft to
assess and confirm graft patency during bypass surgery. Id. "After
completion of the distal coronary artery anastomosis," Taggart injects ICG
dye through the central venous line to visualize flow as SPY images capture
the fluorescent dye passing through grafts to assess patency, and allow for
immediate surgical revision if necessary. Id. at 871-873. Westwick's
endoscopic video system utilizes a multi-mode light source that supplies
light to illuminate a tissue sample for diagnosis. Id. ,r 28. According to
W estwick, "[ c ]linically relevant information about the health of the tissue
under observation may be contained in the intensity of the fluorescence
emission within a specific wavelength range." Id. ,r 30; see e.g., id. ,r 31 (for
example, "green florescence is increasingly suppressed as the tissue
becomes increasingly diseased"). Duhaylongsod's catheter device is for
transilluminating4 an internal blood vessel within a patient during a cardiac
4 Duhaylongsod's catheter 10 includes a fiber optic connector 23 at the
proximal end, which is in optical communication with an energy source that
delivers energy (i.e., visible, infrared, or UV) within a vessel for
illumination, to facilitate locating and manipulating the vessel during a
surgical or endoscopic procedure. Id. ,r,r 27-28.
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surgery procedure to facilitate locating and manipulating the vessel.
Duhaylongsod ,r 1. Duhaylongsod percutaneously inserts the device under
the skin and into a vein to illuminate the vein so that a surgeon can dissect it,
which makes the harvesting procedure "simpler" by facilitating "location
and extraction of the graft vessel." Id. ,r 40.
The presence or absence of a reason "to combine references in an
obviousness determination is a pure question of fact." In re Gartside, 203
F.3d 1305, 1316 (Fed. Cir. 2000) (citation omitted). The difficulty with the
Examiner's reasoning in support of obviousness is twofold. First, contrary
to the Examiner's finding, Taggart is not concerned with locating a blood
vessel to be harvested by observing the ICG fluorescence. See Final Act. 3;
see also Ans. 3 ("Taggart teaches a method for enhancing endoscopic
identification and dissection of a blood vessel in tissue during endoscopic
harvest"). Rather, Taggart's intraoperative injection of ICG into a patient's
bloodstream is for observing the flow of the fluorescent dye as it passes
through the grafted vessel, which is performed "[ a ]fter the completion of the
distal coronary artery anastomosis" (see supra), to evaluate graft patency, or
the degree of openness of the grafted vessel. In other words, by observing
and assessing graft flow, Taggart is able to ascertain any potential occlusion,
as opposed to locating candidate blood vessels for a future CABG. The
objective of Taggart's near real-time fluorescence imaging technique is to
decrease the risk of graft failure post CABG by evaluating graft patency
during bypass surgery so that a surgeon can perform surgical revision if
necessary.
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Second, the Examiner's articulated rationale for combining
Duhaylongsod with Taggart and W estwick lacks reasoning with some
rational underpinning to support the rejection. In response to Appellants'
arguments against the proposed combination (Appeal Br. 12-14), the
Examiner erroneously asserts, "Duhaylongsod is also directed to [an]
endoscopic imaging system for visualizing blood vessel[ s] to be harvested
and used for [a] subsequent procedure, which is commonly shared by both
Taggart and Westwick." Ans. 14. As discussed previously, neither Taggart
nor Westwick aim to visualize blood vessels for harvesting and use in a
subsequent procedure. Taggart observes and assesses the flow rate of
fluorescent dye passing through a placed vein graft during CABG. And,
"the portion of Westwick relied upon by the Examiner (i1i1 [0003]-[0007])
discloses endoscopy 'for the detection and diagnosis of diseases,' which is
completely unrelated to the claimed method for enhancing endoscopic
identification and dissection of a blood vessel." Reply Br. 5.
The Examiner's motivation to combine Duhaylongsod, in which a
catheter is inserted into a vessel to illuminate the vessel from within to assist
a surgeon to dissect and extract it, with Taggart and W estwick because
Duhaylongsod "provides simpler and facilitates location and extraction of
the graft vessel ([0040])" (Final Act. 5; Ans. 5) is conclusory. This
reasoning is inadequate because it fails to explain why one of ordinary skill
in the art would have combined these distinct references to reach the claimed
invention as a whole. The Examiner's rationale appears circular because it
amounts to simply citing a limitation relied upon in Duhaylongsod, and
relying on that same limitation as motivation to combine in reaching the
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conclusion of obviousness. "[R ]ejections on obviousness grounds cannot be
sustained by mere conclusory statements; instead, there must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness." In re Kahn, 441 F.3d 977, 988 (Fed. Cir.
2006); see also KSR Int'! v. Teleflex Inc., 550 U.S. 398,418 (2007).
In view of the foregoing, we do not sustain the Examiner's rejection
of independent claims 1 and 13 under 35 U.S.C. § 103(a). For the same
reasons, we also do not sustain the Examiner's rejection of dependent
claims 2--4, 11, 12, 14--16, and 19. Cf In re Fritch, 972 F.2d 1260, 1266
(Fed. Cir. 1992) ("dependent claims are nonobvious if the independent
claims from which they depend are nonobvious").
Rejection fl
Independent claim 7
We find persuasive Appellants' argument that the Examiner erred in
rejecting independent claim 7 because Hausen, on which the Examiner
relies, fails to disclose the step of "locating the re-inflated blood vessel to be
harvested by observing the ICG fluorescence." Final Act. 7; see also Ans. 7
("blockages located visually by UV light and detecting area which less light
is emitted, [0128]").
In particular, Appellants argue that
Hausen nowhere discloses or suggests the use of ICG
fluorescence to locate the vessel or to harvest the vessel. In fact,
Hausen merely mentions ICG once in paragraph [0128] for use
in a method of locating a blockage in a vessel. Also, while
paragraph [0128] of Hausen discloses the use of ICG in
identifying a blockage in a target vessel, Hausen in no way
discloses or suggests the use of an ICG bolus ( or any type of
bolus) to re-inflate the vessel.
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Application 12/776,835
Appeal Br. 1 7; see also Reply Br. 5-6.
In response to Appellants' argument, the Examiner asserts: "Hausen
teaches fluoroscopic imaging of the target vessel locating the blockage
([0128]), thus teaches claimed invention with a specific use of ICG into the
target vessel." Ans. 15.
Hausen is directed to a method of performing a "minimally-invasive
coronary artery bypass graft procedure." Hausen, Abstract. Paragraph 128
of Hausen discloses, "[ o ]nee the pericardium has been opened, the blockage
or obstruction in the target vessel may be located. A number of methods can
be used to locate the blockage or obstruction." In one method, "indocyanine
green (ICG) dye is injected into the target vessel, causing the target vessel to
glow green under an ultraviolet light. The blockage or blockages are then
located visually by shining ultraviolet light onto the target vessel and
detecting areas of the target vessel from which less light is emitted." Hausen
,r 128.
The disputed limitation of claim 7 requires "locating the re-inflated
blood vessel to be harvested by observing the ICG fluorescence," but
Hausen describes observing the ICG dye injected into target vessels during a
coronary bypass procedure to locate blockages. Putting aside the dispute
over the amount of injected dye that constitutes a "re-inflated" blood vessel,
this relied-upon paragraph in Hausen describes observing the injected dye to
locate a blocked vessel for replacement, rather than locating a candidate
vessel for harvesting, as required by the claim. Hausen teaches that upon
injecting green dye into target vessels, blocked vessels are visually located
by shining UV light onto target vessels, because the blocked vessels emit
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Application 12/776,835
less light and cannot glow green since less dye is able to flow through
blocked vessels. In other words, the blocked vessel is visually located and
selected as an anastomotic site, as compared to an unblocked vessel that
glows green under UV light as the green dye flows through that vessel. As
such, Hausen is observing the ICG dye during a bypass procedure to locate
obstructed vessels, contrary to what the claim requires, which is to locate
candidate blood vessels for harvesting.
Therefore, we do not sustain the rejection of independent claim 7, and
the rejection of claims 9, 10, and 20 dependent thereon.
Rejections III-IV
The rejections of claims 5, 6, 8, 17, and 18, which depend from either
independent claim 1 or 13, are reversed for the same reasons discussed
above with respect to Rejection I (see Final Act. 9-11).
DECISION
The rejections of claims 1-20 are reversed.
REVERSED
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