Ex parte Kirkman

Board of Patent Appeals and Interferences

Dec 22, 1999

08473129 (B.P.A.I. Dec. 22, 1999)

Application for patent filed June 7, 1995. According to1
appellant, this application is a continuation of Application
08/137,619, filed October 15, 1993, now U.S. Patent No.
5,509,900; which is a continuation-in-part of Application
07/844,715, filed March 2, 1992, 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(2) is not binding precedent of the Board.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. 20
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte THOMAS R. KIRKMAN
__________
Appeal No. 1998-1789
Application 08/473,1291
__________
HEARD: Nov. 18, 1999
__________
Before COHEN, ABRAMS, and GONZALES, Administrative Patent
Judges.
ABRAMS, Administrative Patent Judge.
DECISION ON APPEAL
Appeal No. 1998-1789
Application No. 08/473,129
2
This is an appeal from the decision of the examiner
finally rejecting claims 1, 9, 10, 16 and 20-32, which
constitute all of the claims remaining of record in the
application.
The appellant's invention is directed to a catheter
(claims 1, 9, 10, 16, 30 and 31), an assembly including a
catheter (claims 22-29), a method of inserting a catheter
(claims 20 and 21), and a method of securing a catheter tip
(claim 32). The correct copy of the claims on appeal can be
found in an appendix to the Examiner’s Answer.
THE REFERENCES
The references relied upon by the examiner to support the
final rejection are:
Johnson 3,866,599 Feb. 18, 1975
Corrigan et al. 5,167,634 Dec. 1, 1992
(Corrigan) (filed Aug. 22, 1991)
THE REJECTIONS
Claims 1, 9, 10, 16, 20-25 and 27-32 stand rejected under
35 U.S.C. § 102(b) as being anticipated by Johnson.
Appeal No. 1998-1789
Application No. 08/473,129
Rejections of claim 21 under 35 U.S.C. § 112, second2
paragraph, and claims 1, 9, 10, 16 and 20-31 under the
doctrine of double patenting, were overcome, respectively, by
amendment and by the filing of a terminal disclaimer.
3
Claim 26 stands rejected under 35 U.S.C. § 103 as being
unpatentable over Johnson in view of Corrigan.2
Rather than attempt to reiterate the examiner’s full
commentary with regard to the above-noted rejections and the
conflicting viewpoints advanced by the examiner and the
appellant regarding the rejections, we make reference to the
Examiner’s Answer (Paper No. 14) and the Appellant’s Briefs
(Paper Nos. 13 and 16).
OPINION
All but one of the appellant’s claims stands rejected
under 35 U.S.C. § 102(b). The guidance provided by our
reviewing court with regard to the matter of anticipation is
as follows: Anticipation is established only when a single
prior art reference discloses, either expressly or under the
principles of inherency, each and every element of the claimed
invention (see In re Paulsen, 30 F.3d 1475, 1480-1481, 31
USPQ2d 1671, 1675 (Fed. Cir. 1994) and In re Spada, 911 F.2d
705, 708, 15 USPQ2d 1655, 1657 (Fed. Cir. 1990)).
Appeal No. 1998-1789
Application No. 08/473,129
4
Anticipation by a prior art reference does not require either
the inventive concept of the claimed subject matter or
recognition of inherent properties that may be possessed by
the reference (see Verdegaal Bros., Inc. v. Union Oil Co., 814
F.2d 628, 633, 2 USPQ2d 1051, 1054 (Fed. Cir.), cert. denied,
484 U.S. 827 (1987)) or that the reference teach what the
applicant is claiming, but only that the claim on appeal "read
on" something disclosed in the reference, i.e., all
limitations of the claim are found in the reference (see
Kalman v. Kimberly-Clark Corp., 713 F.2d 760, 772, 218 USPQ
781, 789 (Fed. Cir. 1983), cert. denied, 465 U.S. 1026
(1984)). It is only necessary that the reference include
structure capable of performing the recited function in order
to meet the functional limitations of the claim (see In re
Mott, 557 F.2d 266, 269, 194 USPQ 305, 307 (CCPA 1977)).
The appellant’s invention is directed to the solution to
problems occurring in the placement of catheters in long-term
situations such as maintenance dialysis. Objectives of the
invention include preventing the tip of the catheter from
moving laterally into contact with the wall of the vessel in
which it is placed and anchoring the tip of the catheter at a
Appeal No. 1998-1789
Application No. 08/473,129
5
selected location along the length of the vessel, while at the
same time not substantially occluding the vessel such that
stenosis or thrombosis can occur. As manifested in claim 1,
the invention comprises a catheter having tip immobilizing
means on its distal end to “prevent the tip of the catheter
from contacting a wall of the blood vessel without
substantially obstructing fluid flow of blood through the
blood vessel, such that catheter failure due to stenosis or
thrombosis at the catheter distal end is reduced.” Similar
limitations appear in all of the other claims. The examiner’s
position is that the subject matter of all of the others
except claim 26 is anticipated by the catheters shown in
Figures 8-11 of Johnson.
Johnson discloses a catheter within which are positioned
a plurality of light-conducting fibers. The stated objective
of the Johnson invention is to prevent the tips of the light-
conducting fibers from contacting the wall of the vessel in
which they are installed in order to avoid the creation of
artifact by blood flow fluctuations and blood vessel wall
reflectance (column 1, lines 32-59). In the embodiments shown
in Figures 2-7, 10 and 11, Johnson accomplishes this objective
Appeal No. 1998-1789
Application No. 08/473,129
6
by terminating the distal end of the fibers short of the end
of the catheter, that is, inside the catheter. In the
embodiments of Figures 8-11, the tip of the catheter also is
provided with elements that are held within the catheter
during insertion into the vessel, and which are extended
radially outwardly of the catheter when the tip of the
catheter is in the vessel. In Figure 8 this comprises an
annular sleeve, in Figure 9, a plurality of fingers, in Figure
10, a plurality of wire-supported wings, and in Figure 11, a
balloon. These elements also act as an obstruction to blood
flow to generate a force on the tip of the catheter in the
direction of flow, thereby “flow directing” the catheter along
the path of flow (column 4, lines 1-57). There is no explicit
teaching in Johnson that the radially extending elements touch
the wall of the vessel, although it would appear that they do
at least at some time during the operation of the catheter.
There are two structural requirements in claim 1 that in
our view are not disclosed or taught by Johnson. The first is
that claim 1 recites tip immobilizing means which “maintain
the tip of the catheter in a spaced relationship from a blood
vessel wall and prevent the tip of the catheter from
Appeal No. 1998-1789
Application No. 08/473,129
7
contacting a wall of the blood vessel” (emphasis added).
While Johnson discloses elements that extend radially
outwardly of the tip of the catheter, their functions are to
prevent the tips of the light-conducting fibers from
contacting the inner wall of the vessel, and to obstruct the
flow of blood. There is no explicit teaching in the patent
that these elements maintain the catheter spaced from the
walls of the vessel and/or prevent contact between the tip of
the catheter and the vessel wall. Nor, in our opinion, is
there reason to assume that they inherently perform the tasks
set forth in the appellant’s claim 1 or are even capable of
doing so. We arrive at this conclusion for several reasons.
First, the patent does not address any problem associated with
such occurrences. Second, the patent disclosure does not
establish that the elements are strong enough to accomplish
this task. Third, the embodiments of the Johnson invention
shown in Figures 2-7 have no such outwardly extending
elements, which would indicate that Johnson has no concern for
maintaining the tip of the catheter in spaced relationship
from the blood vessel wall and preventing contact therewith,
and that the structure of the outwardly extending elements of
Appeal No. 1998-1789
Application No. 08/473,129
8
Figures 8-11 need be capable only of its stated function of
obstructing blood flow, and not of keeping the tip of the
catheter from contacting the wall of the vessel.
The second shortcoming of Johnson is with regard to the
claim requirement that the tip immobilizing means is of such
structure as to function “without substantially obstructing
fluid flow of blood through the blood vessel, such that
catheter failure due to stenosis or thrombosis at the catheter
distal end is reduced.” The function of the radially
outwardly extending elements in the Johnson device is exactly
the opposite for, as clearly is stated in the patent, they
obstruct blood flow so as to “flow direct” the catheter
through the vessel.
For the reasons set forth above, it is our opinion that
Johnson does not anticipate the subject matter recited in
claim 1, and the rejection is not sustained.
Claim 9 also requires that the tip immobilizing means
maintain the catheter tip a spaced distance from the blood
vessel wall and prevent it from contacting the wall. As the
appellant has argued, this is not taught by Johnson nor is
there reason to assume that this would be inherent in the
Appeal No. 1998-1789
Application No. 08/473,129
9
Johnson devices, as we explained above, and therefore the
rejection of claim 9 as being anticipated by Johnson cannot be
sustained. It then follows that the rejection of claims 10,
16, 30 and 31, all of which are dependent from claim 9, also
will not be sustained. Johnson also does not teach the
features of the wall contact members that are recited in claim
31.
Independent claim 20 sets forth a method of inserting a
catheter which includes the steps of placing in a blood vessel
a sheath insertion tube assembly that has a catheter inside
and is provided with handles at its proximal end, maneuvering
the assembly into selected position within the vessel, and
withdrawing the sheath from the catheter while maintaining the
catheter at a fixed position within the vessel. While Johnson
mentions in passing that the catheter can be inserted by means
of a sheath or needle (column 4, line 33), no information is
provided regarding the structure of the sheath or the method
in which it is used. In addition, claim 20 requires that
there be a tip retainer assembly that contacts the wall of the
vessel with a spring biased force that maintains the catheter
tip anchored at a preselected location and held a selected
Appeal No. 1998-1789
Application No. 08/473,129
10
distance from the blood vessel wall to prevent the catheter
tip from contacting the wall, which also is lacking in
Johnson. In view of these shortcomings, Johnson does not
anticipate the method recited in the appellant’s claim 20.
Nor, it follows, is the reference anticipatory of the subject
matter added by dependent claim 21. The rejection of these
two claims is not sustained.
Claim 22 is directed to an assembly adapted for insertion
into a blood vessel. The assembly comprises a catheter means,
an “introducer assembly means for aid in inserting the said
catheter means,” and a tip retainer assembly means located at
the distal end of the catheter for retaining the tip portion
“in a relatively fixed position within a blood vessel . . . in
a spaced position from the blood vessel wall and preventing
repeated contact of the tip portion of the catheter means with
the blood vessel wall.” While the sheath or needle disclosed
by Johnson (column 4, line 33) can be considered to be
introducer assemblies, for they aid in inserting the catheter
into the blood vessel, for the reasons set forth above the
Johnson fingers and wings do not meet the structural
requirements of the tip retainer assembly as spelled out in
Appeal No. 1998-1789
Application No. 08/473,129
11
the claim. The claim language thus cannot be read on the
Johnson catheters and the claim is not anticipated thereby.
The rejection of independent claim 22 and dependent claims 23-
25 and 27-29 is not sustained.
With regard to these dependent claims, we further note
that Johnson fails to teach the sheath removal means recited
in claim 25 or the spring structure of claims 27-29.
The method recited in claim 32 requires the insertion in a
vessel of a catheter having tip retainer assembly at its distal
end and a control assembly at its proximal end outside of the
vessel, and manipulating the control assembly to deploy tip
retainer assembly into abutting contact with the vessel wall
with sufficient force to maintain the tip anchored at a
preselected location and spaced from the vessel wall to prevent
the catheter tip from repeatedly contacting the wall. The
latter feature is not taught by Johnson, as we have explained
above. The former one also is not taught by Johnson, in that
the radially extending elements of Johnson are for the purpose
of facilitating movement of the catheter through the vessel,
rather than anchoring it at a selected position. The rejection
of this claim is not sustained.
Appeal No. 1998-1789
Application No. 08/473,129
The test for obviousness is what the combined teachings3
of the prior art would have suggested to one of ordinary skill
in the art. See, for example, In re Keller, 642 F.2d 413,
425, 208 USPQ 871, 881 (CCPA 1981).
12
Claim 26, which is dependent from independent claim 22 by
way of claims 23-25, stands rejected as being unpatentable over
the combined teachings of Johnson and Corrigan, which was cited
for its teaching of forming a catheter introducing sheath of a
tearable membrane. Be that as it may, even considering Johnson
in the light of 35 U.S.C. § 103, the teachings of Corrigan fail3
to alleviate the shortcomings regarding maintaining the catheter
spaced from the walls of the vessel, which have been explained
above with regard to the subject matter recited in claim 22.
This rejection is not sustained.
Appeal No. 1998-1789
Application No. 08/473,129
13
SUMMARY
None of the rejections are sustained.
The decision of the examiner is reversed.
REVERSED
Irwin Charles Cohen )
Administrative Patent Judge )
)
)
)
Neal E. Abrams ) BOARD OF
PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
)
)
John F. Gonzales )
Administrative Patent Judge )
tdl
Appeal No. 1998-1789
Application No. 08/473,129
14
SEED AND BERRY
David V. Carlson
6300 Columbia Center
Seattle, WA 98104-7092