Ex Parte Tran et al

Board of Patent Appeals and Interferences

May 30, 2002

08838685 (B.P.A.I. May. 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for publication and is not binding precedent of the Board.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. 22
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte QUANG Q. TRAN, MARLOWE PATTERSON, HENRY NITA
and PAUL C. SLAIKEU
____________
Appeal No. 2000-0447
Application No. 08/838,685
____________
ON BRIEF
____________
Before NASE, CRAWFORD, and BAHR, Administrative Patent Judges.
CRAWFORD, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal from the examiner’s final
rejection of claims 1 through 9, which are the only claims pending
in this application.
The appellants’ invention relates to a catheter having an
elongate tubular member. An understanding of the invention can be
derived from a reading of claim 1, which appears in the appendix to
the appellants’ brief.
Appeal No. 2000-0447
Application No. 08/838,685
2
THE PRIOR ART
The prior art references of record relied upon by the examiner
in rejecting the claims are:
Bodicky 4,333,455 June 8, 1982
Heyman 4,571,239 Feb. 18, 1986
Amiel 5,342,350 Aug. 30, 1994
Mikhail et al. (Mikhail) 5,624,395 Apr. 29, 1997
Gore et al. (Gore) 5,662,622 Sep. 2, 1997
THE REJECTIONS
Claims 1, 7 and 8 stand rejected under 35 U.S.C. § 102(e)
as being anticipated by Gore.
Claim 2 stands rejected under 35 U.S.C. § 103 as being
unpatentable over Gore in view of Mikhail.
Claims 3 and 4 stand rejected under 35 U.S.C. § 103 as being
unpatentable over Gore in view of Amiel.
Claim 5 stands rejected under 35 U.S.C. § 103 as being
unpatentable over Gore in view of Heyman.
Claim 6 stands rejected under 35 U.S.C. § 103 as being
unpatentable over Gore.
Claim 9 stands rejected under 35 U.S.C. § 103 as being
unpatentable over Gore in view of Bodicky.
Rather than reiterate the conflicting viewpoints advanced by
the examiner and the appellants regarding the above-noted
Appeal No. 2000-0447
Application No. 08/838,685
3
rejections, we make reference to the answer (Paper No. 15) for the
examiner’s complete reasoning in support of the rejections, and to
the brief (Paper No. 14) for the appellants’ arguments
thereagainst.
OPINION
In reaching our decision in this appeal, we have give careful
consideration to the appellants’ specification and claims, the
applied prior art references, and to the respective positions
viewpoints articulated by the appellants and the examiner. As a
consequence of our review, we make the determinations which follow.
We turn first to the examiner’s rejection of claims 1, 7 and 8
under 35 U.S.C. § 102(e) as anticipated by Gore. The examiner
found that Gore discloses:
. . . a catheter with a proximal section (25) that has a
tapered joint (40) that joins the intermediate section
(26). The intermediate section has a tapered joint (39)
that joins the distal section (27&28), see fig. 1. The
flexibility of the catheter increase from the proximal
end of the catheter tube (18) to the distal end (16), see
col. 4, lines 47-50. The distal portion (27&28) has a
relatively constant diameter, and there is another
portion of the distal section (28) that has a different
diameter. [answer at pages 3-4].
Appellants argue that Gore does not anticipate claim 1 because
Gore does not disclose a blood-flow directable catheter.
Appeal No. 2000-0447
Application No. 08/838,685
4
Appellants are of the opinion that the preamble of claim 1 from
which claims 2 through 9 depend breathes life and meaning into the
claim.
The examiner argues that the term “blood-flow directable
catheter” is ambiguous and as such does not breath life into the
meaning of the claim in terms of a structural limitation. The
examiner further states that even if this term in the preamble does
breath life and meaning into the claims, the structural limitations
of a flow directed catheter as defined by appellants are taught by
Gore.
We note at the outset that the question of whether a preamble
constitutes a limitation to a claim is a matter to be determined by
the facts of each case in view of the claimed invention as a whole.
See In re Stencel, 828 F.2d 751, 754, 4 USPQ2d 1071, 1073 (Fed.
Cir. 1987). The preamble of a claim does not limit the scope of
the claim when it merely states intended use of the invention. In
re Pearson, 494 F.2d 1399, 1403, 181 USPQ 641, 644 (CCPA 1974).
However, terms in a preamble are construed as limitations when they
give life and meaning to the invention claimed. Gerber Garment
Technology, Inc. v. Lectra Syst., Inc., 916 F.2d 683, 688, 16
USPQ2d 1436, 1441 (Fed. Cir. 1990)(quoting) Perkins-Elmer Corp. v.
Computervision Corp., 732 F.2d 888, 896, 221 USPQ 669, 675 (Fed.
Appeal No. 2000-0447
Application No. 08/838,685
5
Cir.), cert. denied, 469 U.S. 857 (1984). Although no “litmus
test” exists as to what effect should be accorded to terms
appearing in a preamble, a patent application in its entirety
should be reviewed to determine whether the inventors intended such
language to represent additional limitations or mere introductory
language. See, e.g., In re Paulsen, 30 F.3d 1475, 1479, 31 USPQ2d
1671, 1673-74 (Fed. Cir. 1994)(citing Corning Glass Works v.
Suitomo Elect. U.S.A., Inc., 868 F.2d 1251, 1257, 9 USPQ2d 1962,
1966 (Fed. Cir. 1989).
A review of appellants’ specification reveals that appellants’
flow directed catheter is so flexible at its distal end and mid
regions that it is carried by blood flowing to a target site
(specification at page 2). The appellants’ specification further
discloses that the distal end therein disclosed is made of polymer
which is inherently quite springy and flexible and biologically
compatible such as polyvinylchloride (specification at page 4).
Regarding the softness of the distal end, appellants’ specification
discloses that the distal end has a hardness of between 60A and 70A
shore.
Appeal No. 2000-0447
Application No. 08/838,685
1 The appellants filed this declaration with the reply brief
in response to the arguments made by the examiner for the first
time in the answer. As the reply brief, Nita declaration and
Taveras article were all filed and entered as a single paper
(Paper No. 17), we interpret the examiner’s statement in Paper
No. 18 as an approval of the entry of the reply brief and
attached declaration and article.
6
Appellants have also filed a declaration executed1 by Henry
Nita which states:
It is well known in the practice of medicine that flow-
directed catheters are a class of catheters considered
separate from guidewire-directed catheters. Flow-
directed catheters are comparatively more flexible and
are positioned at a target site by the flow of blood. In
contrast, typically stiffer guidewire-directed catheters
are pushed over a guidewire to a target site. [Nita
declaration at page 2].
The appellants have filed a copy of Juan M. Taveras, MD,
Neuroradiology, (Waverly Company), Chapter 18.2, page 1050,
which states:
Flow-directed microcatheters have a very soft, floppy,
distal segment that is carried by the blood flow (16).
The stiff proximal portion allows the distal segment to
be advanced through the catheter. ... With these
catheters it is usually possible to reach almost any
vessel, even those with very small flows, by using the
appropriate curve and manipulation.
In view of the foregoing, it is our view that the term “flow
directed catheter” is a catheter with a distal end which is so soft
that it can be carried to the target site by blood. As such, the
term “flow directed catheter” is not ambiguous.
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Application No. 08/838,685
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In addition, in our view, the phrase in the preamble of
claim 1 i.e., “blood-flow directable catheter” is a catheter
constructed of materials and having a size and flexibility such
that the catheter is directable to a target site by blood flow and
as such the “blood-flow directable catheter” does breath life and
meaning into claim 1.
To support a rejection of a claim under 35 U.S.C. § 102(e),
it must be shown that each element of the claim is found, either
expressly described or under principles of inherency, in a single
prior art 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). The prior art reference need not expressly
disclose each claimed element in order to anticipate the claimed
invention. See Tyler Refrigeration v. Kysor Indus. Corp., 777 F.2d
687, 689, 227 USPQ 845, 846-847 (Fed. Cir. 1985). Rather, if a
claimed element (or elements) is inherent in a prior art reference,
then that element (or elements) is disclosed for purposes of
finding anticipation. See Verdegaal Bros., Inc. v. Union Oil Co.,
814 F.2d 628, 631-33, 2 USPQ2d 1051, 1052-54 (Fed. Cir.)
cert. denied, 484 U.S. 827 (1987).
It is well settled that the burden of establishing a prima
facie case of anticipation resides with the Patent and Trademark
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Application No. 08/838,685
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Office (PTO). See In re Piasecki, 745 F.2d 1468, 1472, 223 USPQ
785, 788 (Fed. Cir. 1984). When relying upon the theory of
inherency, the examiner must provide a basis in fact and/or
technical reasoning to reasonably support the determination that
the allegedly inherent characteristic necessarily flows from the
teachings of the applied prior art. See Continental Can Co. v.
Monsanto Co., 948 F.2d 1264, 1268, 20 USPQ2d 1746, 1749 (Fed Cir.
1991); Ex parte Levy, 17 USPQ2d 1461, 1464 (Bd. Pat. App. & Int.
1990).
After the PTO establishes a prima facie case of anticipation
based on inherency, the burden shifts to the appellant to prove
that the subject matter shown to be in the prior art does not
possess the characteristics of the claimed invention. See In re
Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985);
In re King, 801 F.2d 1324, 1327, 231 USPQ 136, 138 (Fed. Cir.
1986). Gore discloses a intravascular catheter which has a
proximal section which has a softness of 75A shore. The
appellants’ catheter has a distal section with a softness
between 55A and 75A shore. Gore discloses a midsection with a
softness of 65A shore. The appellants’ midsection has a softness
between 65A and 85A shore. Gore’s distal end has a softness of 80A
shore. Appellants disclose a distal end with a softness between
Appeal No. 2000-0447
Application No. 08/838,685
9
55A and 75A shore. Gore discloses that the distal portion is
comprised of a polyurethane (col. 5, lines 29 to 41). In addition,
as argued by the examiner:
. . . the diameter of the proximal section of Appellants’
catheter is typically between 2.9 F and 3.5 F.
Similarly, the diameter of proximal section of the Gore
catheter is 3 F. The diameter of the distal section of
Appellants’ catheter is preferably between 1 F. and
2.5 F. Similarly, the diameter of the distal section of
the Gore catheter is 2.5 F. [answer at pages 8 to 9].
The examiner further states that:
Furthermore, even if one considers the phrase to “breathe
life and meaning,” those limitations incorporated from
Appellants’ Specification concerning materials and sizes
are either identical to or very similar to those of Gore
et al. [answer at page 10].
In essence the examiner argues that the Gore catheter is inherently
flow directable. While it is possible that the Gore catheter may
be flow directable because of the identity of the size of the
catheter and the similarity in the shore hardness of the various
sections of the catheter, mere possibilities are not enough. The
Gore disclosure does not mention flow directability. The shore
hardness of the Gore distal section which is an important in view
of the feature of flow directability is 80 A while the disclosed
distal section has a shore hardness of 55A to 75A (specification
at page 5). In addition, the Gore catheter is provided with by a
helical coil reinforcement 42 which may affect the flexibility and
Appeal No. 2000-0447
Application No. 08/838,685
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thus the ability to be flow directed of the Gore catheter.
Therefore, we are of the opinion that the finding that the Gore
catheter is flow directable is speculative. Inherency, however,
can not be established by probabilities or possibilities. The mere
fact that a certain thing may result from a given set of
circumstances is not sufficient. Id., 948 F.2d at 1269, 20 USPQ2d
at 1749 (quoting In re Oelrich, 666 F.2d 578, 581, 212 USPQ 323,
326 (CCPA 1981). As such, the examiner has failed to establish a
prima facie case of anticipation by inherency and we will therefore
not sustain this rejection.
We will likewise not sustain the remaining references as these
references do not cure the deficiency noted above for the Gore
reference.
Appeal No. 2000-0447
Application No. 08/838,685
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The decision of the examiner is reversed.
REVERSED
JEFFREY V. NASE )
Administrative Patent Judge )
)
)
)
) BOARD OF PATENT
MURRIEL E. CRAWFORD ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
)
JENNIFER D. BAHR )
Administrative Patent Judge )
MEC/jrg
Appeal No. 2000-0447
Application No. 08/838,685
12
SCIMED LIFE SYSTEMS, INC.
ONE SCIMED PLACE
M.S. A150,
MAPLE GROVE, MN 55311-1566