Ex parte Lazarus

Board of Patent Appeals and Interferences

Jan 19, 2000

08460311 (B.P.A.I. Jan. 19, 2000)

Application for patent filed June 2, 1995. According to appellant,1
this application is a divisional of application no. 08/149,040, filed November
8, 1993, now abandoned.
1
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today (1)
was not written for publication in a law journal and (2) is
not binding precedent of the Board.
Paper No. 16
UNITED STATES PATENT AND TRADEMARK OFFICE
_____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
_____________
Ex parte HARRISON M. LAZARUS
_____________
Appeal No. 1998-2095
Application No. 08/460,3111
______________
ON BRIEF
_______________
Before COHEN, McQUADE and GONZALES, Administrative Patent
Judges
GONZALES, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on an appeal from the examiner's final
rejection of claims 30 through 41, which are all of the claims
Appeal No. 1998-2095
Application No. 08/460,311
2
remaining in the application.
The invention is directed to a method of implanting an
intraluminal vascular graft within a diseased or damaged
vessel.
The subject matter before us on appeal is illustrated by
reference to claims 30 and 39 which, along with the other
claims on appeal, have been reproduced in "Appendix A"
attached to the main Brief (Paper No. 12).
The prior art references of record relied upon by the
examiner in rejecting the appealed claims are:
Lazarus 5,104,399 Apr. 14,
1992
Kwan-Gett 5,151,105 Sep.
29, 1992
Barone et al. (Barone) 5,360,443 Nov. 01,
1994
(Filed Jun. 11, 1990)
The following rejections are before us for review:
Claims 30, 31 and 33 through 41 stand rejected under
35 U.S.C. § 103 as being unpatentable over Lazarus in
view
of Barone; and
Claim 32 stands rejected under 35 U.S.C. § 103 as being
Appeal No. 1998-2095
Application No. 08/460,311
3
unpatentable over Lazarus in view of Barone, as applied to
claims 30 and 31 above, and further in view of Kwan-Gett.
The full text of the examiner's rejections and the
responses to the arguments presented by appellant appear in
the final rejection (Paper No. 8, mailed April 29, 1997) and
the Answer (Paper No. 13, mailed January 23, 1998), while the
complete statement of appellant's arguments can be found in
the Main and Reply Briefs (Paper Nos. 12 and 14, filed
September 29, 1997 and March 20, 1998, respectively).
OPINION
In reaching our decision in this appeal, we have given
careful consideration to the appellant's specification and
claims, to the applied prior art references, and to the
respective positions articulated by the appellant and the
examiner. As a consequence of our review, we have made the
determinations which follow.

The rejection of claims 30, 31 and 33-41
We reverse the examiner’s rejection of claims 30, 31 and
33 through 41 under 35 U.S.C. § 103.
Appeal No. 1998-2095
Application No. 08/460,311
4
In rejecting claims under 35 U.S.C. § 103 the examiner
bears the initial burden of presenting a prima facie case of
obviousness. In re Rijckaert, 9 F.3d 1531, 1532, 28 USPQ2d
1955, 1956 (Fed. Cir. 1993); In re Oetiker, 977 F.2d 1443,
1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992). Only if that
burden is met does the burden of coming forward with evidence
or argument shift to the applicant. Id. If the examiner
fails to establish a prima facie case, the rejection is
improper and will be overturned. In re Fine, 837 F.2d 1071,
1074, 5 USPQ2d 1596, 1598 (Fed. Cir. 1988). In order to
establish the prima facie obviousness of a claimed invention,
all the claim limitations
must be taught or suggested by the prior art. In re Royka,
490 F.2d 981, 985, 180 USPQ 580, 583 (CCPA 1974).
We begin our review with independent claim 30. We note
that claim 30 calls for a method of implanting an intraluminal
vascular graft within a diseased or damaged vessel comprising,
inter alia,
. . . attaching said intraluminal vascular graft to the
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inner wall of said vessel by initiating a non-
perforating, inflammatory response between said
intraluminal vascular graft and said inner wall of said
vessel. . . .
The examiner describes Lazarus as disclosing the
invention substantially as claimed, except for the step of
attaching the graft to the inner wall of the vessel by
initiating a non-perforating, inflammatory response between
the graft and the inner wall of the vessel (Answer, pages 4
and 5). Instead, Lazarus teaches attaching the graft to the
wall of the lumen with staples or anchoring elements 16, 17
(see col. 3, lines 50-65 and Figure 2). Barone is cited by
the examiner for teaching a vascular graft securing means 165
including a thin-walled member 166 having a smooth outer wall
surface 169 (Answer, page 5). It is the examiner’s position
that it would have been obvious to modify the method taught by
Lazarus by replacing the vascular
graft of Lazarus with the graft taught by Barone in order “to
prevent perforation of the blood vessel” (id.) As to the step
of attaching the vascular graft to the inner wall of the
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vessel by initiating an inflammatory response between the
vascular graft and the inner wall of the vessel, the examiner
asserts that “insertion of any prosthetic device will initiate
an inflammatory response and therefore cause attachment”
(id.).
Appellant argues that Barone neither teaches nor suggests
a configuration of the disclosed securing means to initiate an
inflammatory response to facilitate attachment of the graft to
the intima or inner wall of the vessel (Brief, page 8).
Further, the appellant argues that “while all things implanted
in the body may cause an inflammatory response or irritation .
. . not all inflammatory responses are of the degree which
provides attachment of the device to the surrounding body
tissue” (Reply Brief, pages 1 and 2).
Since the examiner has not directed our attention to any
particular language in Barone which explicitly supports the
position taken by the examiner, we understand the rejection to
be based on the examiner’s determination that insertion of
Barone’s intraluminal vascular graft into a vessel will not
only initiate
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7
an inflammatory response between the graft and the inner wall
of the vessel, but that the inflammatory response of the inner
wall will inherently result in the attachment of the graft to
the inner wall of the vessel.
Like the appellant, we do not agree with the examiner’s
position. We are informed by appellant’s specification
that the attachment of vascular graft 20 may be accomplished
by providing means or material which initiates an inflammatory
response in the vessel intima or inner wall (page 22).
Appellant teaches, for example, that the longitudinal and/or
circumferential support structures may be constructed of a
material, or may be coated with a material, which induces an
inflammatory response. According to appellant, such materials
may include polylactic acids, polyglycolic acids or polyamino
acids. Other materials disclosed as initiating an
inflammatory response include cat gut, cellulose and nylon.
Barone, on the other hand, teaches that the graft or tube 160
is made of a material compatible with the patient’s body, e.
g., DACRON®, TEFLON® or TEFLON® coated DACRON® and porous
polyurethane (col. 6, lines 55-66) and that the tube 160 or
securing means 165 may have a coating of biologically inert
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material, e. g., TEFLON® or
porous polyurethane (col. 7, lines 16-19). Further, Barone
teaches that “the thin-walled member 166 is forced radially
outwardly into contact with the aorta 152 to remain secured
thereto” (id. at 46-48). Given that Barone fails to teach or
suggest any of the inflammation-inducing materials taught in
appellant’s specification and teaches that the tube 160 is
attached to the aorta by forcing the thin-walled member 166
radially outwardly into contact with the aorta, we find the
examiner’s apparent position that the inflammatory response of
the inner wall of the vessel to Barone’s tube 160 or securing
means 165 will inherently result in the attachment of the
graft to the inner wall of the vessel to be speculative and
unsupportable.
It is well settled that inherency may not be established
by probabilities or possibilities, but must instead be "the
natural result flowing from the operation as taught." See In
re Oelrich, 666 F.2d 578, 581, 212 USPQ 323, 326 (CCPA 1981).
In the present case, the examiner has not explained how the
Barone reference provides factual basis to establish that the
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Application No. 08/460,311
9
natural result flowing from following the teachings of Barone
would be an
inflammatory response between the intraluminal graft and the
inner wall of the diseased or damaged vessel sufficient to
result in the attachment of the graft to the inner wall of the
vessel as claimed by appellant. Accordingly, since all the
limitations of appellant’s claim 30 are not found in the
applied prior art or obvious therefrom, it follows that the
examiner's rejection of claim 30 under 35 U.S.C. § 103 will
not be sustained.
Claims 31 and 33 through 38 are dependent on claim 30
and, therefore, contain all of the limitations of that claim.
Therefore, we will also not sustain the standing 35 U.S.C. §
103 rejection of claims 31 and 33 through 38.
Turning next to independent claim 39, we note that claim
39 calls for a method of implanting an intraluminal vascular
graft within a diseased or damaged vessel which is bifurcated
along its length and does not call for the step of attaching
the intraluminal vascular graft to the inner wall of said
vessel by initiating a non-perforating, inflammatory response
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Application No. 08/460,311
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between the graft and the inner wall of said vessel. Instead,
claim 39 calls for
. . . compressing an intraluminal vascular graft
structure to provide a reduced circumferential dimension
sized to be receivable within said transportation
structure, said intraluminal vascular graft structure
comprising a tubular
body having an expandable frame structure including a
circumferential support structure positioned to contact
and
span the bifurcation of a bifurcated vessel . . . and
supporting said intraluminal vascular graft structure
within said bifurcated vessel by positioning said
circumferential support structure at the bifurcation of
the bifurcated vessel to be supported by the bifurcation.
. . .
Appellant argues that “[a] method of supporting a
vascular graft on the cusp of a bifurcated vessel by use of a
circumferential support is not disclosed by either Lazarus
‘399 or Barone, et al.” (Brief, page 9). The examiner’s
position is that the language “vascular graft structure
comprising a tubular body having an expandable frame structure
including a circumferential support structure positioned to
contact and span the bifurcation of a bifurcated vessel” is
unclear and can be construed to mean that it is the vascular
graft, not the circumferential support structure, which is
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Application No. 08/460,311
11
intended to contact the bifurcation and that Barone shows, in
Figure 4, a vascular graft contacting the bifurcation (Answer,
pages 7 and 8).
We do not agree. Appellant’s Figure 11 illustrates a
preferred embodiment of an intraluminal vascular graft for
repairing bifurcated vessels. With regard to this particular
embodiment, page 24 of the specification informs us that when
the
vascular graft 20 is deployed in a bifurcating vessel, “the
expandible caudal ring 35 is seated upon and supported by the
bifurcation of the vessel, otherwise referred to as the crotch
98 of the bifurcation.” Thus, based on the underlying
specifi-cation, we understand the claim language referred to
by the examiner as being unclear, unambiguous and as actually
requiring that the circumferential support structure, not the
vascular graft, be capable of being positioned to contact and
span the bifurcation. Furthermore, this interpretation is
consistent with the step of “supporting said intraluminal
vascular graft structure within said bifurcated vessel, by
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12
positioning said circumferential support structure at the
bifurcation of the bifurcated vessel to be supported by the
bifurcation” (emphasis added) recited in claim 39. In
addition, in order to be “supported by the bifurcation,” the
circumferential support structure must be seated upon the
bifurcation of the vessel, again consistent with the
underlying specification. We find no corresponding teaching
or suggestion in Barone. In Figure 4, Barone does not show
the thin-walled member 166 (which corre-sponds to the claimed
circumferential support structure) seated upon or supported by
the crotch of the bifurcation.
Since all the limitations of claim 39 would not have been
taught or suggested by the combined disclosures of Lazarus and
Barone, it follows that the examiner has not established the
prima facie obviousness of the invention set forth in claim
39. See In re Royka, supra. Thus, the examiner's rejection
of claim 39 under 35 U.S.C. § 103 will not be sustained.
Claims 40 and 41 are dependent on claim 39 and contain
all of the limitations of that claim. Therefore, we will also
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Application No. 08/460,311
13
not sustain the standing 35 U.S.C. § 103 rejection of claims
40 and 41.
The rejection of claim 32
Claim 32 is dependent on claim 31, which, in turn, is
dependent on claim 30. Our review of the Kwan-Gett reference,
which is used in combination with Lazarus and Barone in the
rejection of claim 32, indicates to us that this reference
does not supply the deficiencies in the combined teachings of
Lazarus and Barone noted above with regard to claim 30 on
appeal. Accordingly, the examiner’s rejection of claim 32
under 35 U.S.C. § 103 will not be sustained.
In summary, all of the examiner's rejections of claims 30
through 41 are reversed.
REVERSED
Appeal No. 1998-2095
Application No. 08/460,311
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IRWIN CHARLES COHEN )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
JOHN P. McQUADE ) APPEALS AND
Administrative Patent Judge ) INTERFERENCES
)
)
)
JOHN F. GONZALES )
Administrative Patent Judge )
vsh
Appeal No. 1998-2095
Application No. 08/460,311
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Julie K. Morriss
Trask, Britt & Rossa
P.O. Box 2550
Salt Lake City, UT 84110