Ex Parte Lazarus

Board of Patent Appeals and Interferences

Jul 30, 2002

08748637 (B.P.A.I. Jul. 30, 2002)

The opinion in support of the decision being entered today was not
written for publication and is not binding precedent of the Board.
Paper No. 42
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte HARRISON M. LAZARUS
____________
Appeal No. 2000-1759
Application No. 08/748,637
____________
HEARD: July 9, 2002
____________
Before COHEN, ABRAMS, and FRANKFORT, Administrative Patent
Judges.
FRANKFORT, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal from the examiner's final
rejection of claims 39 through 42, which are all of the claims
remaining in this application. Claims 1 through 38 have been
canceled.
Appellant's invention relates to a minimally invasive method
for repairing a diseased portion of a corporeal lumen of a
patient's vasculature. Independent claims 39 and 42 are
Appeal No. 2000-1759
Application No. 08/748,637
1 Our understanding of this foreign language document is
based on a translation apparently submitted by appellant.
2
representative of the subject matter on appeal and a copy of
those claims may be found in the Appendix to appellant's brief.
The prior art references of record relied upon by the
examiner in rejecting the appealed claims are:
Choudhury 4,140,126 Feb. 20, 1979
Kononov SU 660689 May 5, 1979
(Russian Inventor's Certificate)1
Claims 39 through 42 stand rejected under 35 U.S.C. § 103(a)
as being unpatentable over Choudhury in view of Kononov.
Rather than reiterate the examiner's full statement of the
above-noted rejection and the conflicting viewpoints advanced by
the examiner and appellant regarding the rejection, we make
reference to the examiner's answer (Paper No. 31, mailed May 19,
2000) for the reasoning in support of the rejection, and to
appellant' brief (Paper No. 29, filed March 2, 2000) and reply
brief (Paper No. 34, filed July 27, 2000) for the arguments
thereagainst.
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Application No. 08/748,637
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OPINION
In reaching our decision in this appeal, we have given
careful consideration to appellant's specification and claims, to
the applied prior art references, to the declarations filed by
Morton J. Thoshinsky, M.D., and to the respective positions
articulated by appellant and the examiner. As a consequence of
our review, we have made the determination that the examiner's
above-noted rejection will not be sustained. Our reasons follow.
In evaluating the prior art applied by the examiner, we note
that Choudhury discloses a method and device for permitting
intraluminal repair of an aneurysm (20) in a patient's aorta
(10). A primary object of the invention in Choudhury (col. 1,
lines 30-34) is to provide a method and article for performing an
aneurysm repair "which does not require major surgery and may
therefore be used on higher risk patients than conventional
excisional aneurysm surgery." More specifically, Choudhury
teaches a method of repairing a diseased portion (20) of a first
corporeal lumen (aorta 10) comprising the steps of:
intraluminally inserting a repair device (22) into a second
corporeal lumen (femoral artery 48) at a location remote from the
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first corporeal lumen, wherein the second corporeal lumen
branches from the first corporeal lumen; and using a catheter
(34) having a mechanical expanding means thereon to advance the
repair device (22) from the entry point in the second corporeal
lumen to the first corporeal lumen, the repair device being
carried in a collapsed form on the exterior of the catheter and
in association with the mechanical expanding means. Once the
repair device is properly positioned in the first corporeal lumen
at the site needing repair (Fig. 1), the mechanical expanding
means is operated to cause expansion of the collapsed repair
device and to cause the anchoring pins (28) at each end of the
repair device to pierce the healthy artery wall (18) on opposite
ends of the aneurysm, thus anchoring the repair device in place
(Figs. 2 and 4). Choudhury notes that his invention is intended
to provide a more favorable mortality rate as a result of the
less severe surgical technique involved therein.
In contrast to Choudhury, Kononov discloses a highly
invasive, major form of surgery and an aneurysm repair device for
use therein. As noted on page 2 of the translation, the surgery
begins by uncovering the bifurcation of the aorta on the left,
starting from a retroperitoneal entrance at the patient's back,
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placing the aorta on a tourniquet and transversely cutting the
aorta. A resilient tubular casing (1) housing the repair device
(3), which device is wound onto and carried by a prosthesis-
fitting means (5) having inflatable bulb structures (6), is
inserted into the open end of the aorta formed by the transverse
cut. Once properly positioned in the aorta, a pump (7) supplies
a physiological solution through the rubber pipes (8) to the
resilient bulbs (6) which, with the help of the spring-operated
carriage (10) and the flexible linkages (11), guide the repair
device in the radial direction until it is fully in contact with
the inner wall of the aorta, where the splints or pins on the
brackets (4) at each end of the repair device are thrust into the
walls of the aorta by the force generated by the bulbs (6)
inflated with physiological solution. Subsequently, the
physiological solution is drawn off and the resilient bulbs (6)
return to their original deflated position. The flexible
linkages (11) which held the repair device in a collapsed
position on the prosthesis-fitting means (5) are then cut and the
placement mechanism for the repair device is extracted from the
aorta and the aorta sewn up by the usual method. Likewise, the
retroperitoneal entrance would be closed by the usual method.
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The examiner urges (answer, page 4) that it would have been
obvious to one of ordinary skill in the art at the time of
appellant's invention (circa 1983) "to have utilized the
inflatable portion of Kononov with the method of Choudhury such
that the repair device could be securely implanted into the lumen
by the highly controllable expansion force generated by the
inflatable portion." For a variety of reason set forth in the
brief, reply brief and declarations by Dr. Thoshinsky, appellant
argues that the examiner's conclusion of obviousness is improper
because, in the relevant time frame, there would have been no
motivation to modify Choudhury's method to use Kononov's step of
balloon expansion.
After a careful assessment of all of the evidence before us,
we agree with appellant that one of ordinary skill in the art at
the time of appellant's invention would have found no motivation
in the references applied in the rejection before us on appeal
for making the combination urged by the examiner (i.e., for
taking the balloon expansion portion and associated expansion
step in Kononov and attempting to employ them in the particular
repair device and minimally invasive surgical method disclosed in
Choudhury).
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Like appellant, we find that, in the relevant time frame
(circa 1983), a person of ordinary skill in the art would not
have looked to the invasive, aortic surgical repair method of
Kononov and a device like that of Kononov, wherein the device is
sized to be inserted directly into an opening formed in the aorta
itself, to modify a minimally-invasive repair method like that in
Choudhury where the repair device is inserted at a location
remote from the aorta, such as the smaller femoral artery in a
patient's leg, and then fed through the patient's vasculature to
the point in the aorta where repair is needed. In that regard,
we note that the examiner has essentially provided no response to
the evidence and arguments presented by appellant in the
declarations by Dr. Thoshinsky and the brief and reply brief.
More specifically, the declarations by Dr. Thoshinsky, who
practiced in the field of vascular surgery for 38 years and
during the relevant time frame of 1979 through 1983, set forth
numerous reasons why one of ordinary skill in the art at the time
of appellant's invention would have found no motivation in the
references applied by the examiner for making the combination
urged in the rejection on appeal, and instead would have found
many disincentives in those references for attempting to make
such a combination. In the face of appellant's evidence setting
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forth why Kononov's balloon expansion step would have been
incompatible with Choudhury's method, the examiner stands silent,
having provided no response to the declaration evidence.
Moreover, like appellant, we find that the examiner's
specific rationale for the combination, i.e., to obtain a "highly
controllable expansion force generated by the inflatable
portion," is without foundation in the references themselves and
appears to be based on pure speculation and conjecture on the
examiner’s part. Again, the examiner has provided no cogent
response to appellant's arguments and evidence to the effect that
substituting the inflatable expansion system of Kononov in the
system and method in Choudhury would actually have the
undesirable effect of sacrificing control.
In the final analysis, we agree with appellant that the
examiner has failed to establish a prima facie case of
obviousness. Since the combined teachings of the applied
references to Choudhury and Kononov would not have rendered the
subject matter of appellant's claims on appeal obvious to one of
ordinary skill in the art at the time appellant's invention was
made, we will not sustain the examiner's rejection of claims 39
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through 42 under 35 U.S.C. § 103. Thus, the decision of the
examiner is reversed.
REMAND TO THE EXAMINER
In addition to the foregoing, we REMAND this application to
the examiner for a full consideration of the teachings in the
declaration by Dr. Stanley N. Carson, cited by appellant in the
Information Disclosure Statement filed September 22, 2000 (Paper
No. 33). More particularly, we direct the examiner's attention
to the disclosure therein at paragraphs 5 through 10, which would
appear to teach or suggest a method of stent placement and stent
expansion utilizing a catheter with a radially expandable portion
exactly like that set forth in appellant's claims 39 through 42
on appeal. This declaration states (paragraph 6) that the
concept of a permanently expandable metal stent that could be
inserted over an angioplasty balloon and delivered percutaneously
to the point of vessel blockage and then inflated to open up the
vessel and thereafter deflated and withdrawn leaving the stent in
place in the vessel to keep it open was conceived of by Dr.
Carson during the latter part of 1979 and pursued into the early
1980's, a time frame before the earliest date established by
appellant for his invention (i.e., as indicated in appellant's
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declaration under 37 CFR § 131 (Paper No. 13, filed May 20,
1998), "prior to September 29, 1983"). The examiner should make
a determination on the record as to whether or not the disclosure
in the declaration by Dr. Carson constitutes knowledge or use
which was accessible to the public and therefore would be
available as prior art under 35 U.S.C. §§ 102(a) or 102(b).
REVERSED & REMANDED
IRWIN CHARLES COHEN )
Administrative Patent Judge )
)
)
)
) BOARD OF PATENT
NEAL E. ABRAMS ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
)
CHARLES E. FRANKFORT )
Administrative Patent Judge )
CEF/LBG
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