Ex Parte Kampa et al

Board of Patent Appeals and Interferences

May 3, 2012

11470488 (B.P.A.I. May. 3, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/470,488 09/06/2006 GREG J. KAMPA 1001.1538103 8116
11050 7590 05/03/2012
SEAGER, TUFTE & WICKHEM, LLC
1221 Nicollet Avenue
Suite 800
Minneapolis, MN 55403
EXAMINER
MEDWAY, SCOTT J
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
05/03/2012 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte GREG J. KAMPA and PU ZHOU
__________

Appeal 2011-001625
Application 11/470,488
Technology Center 3700
__________

Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a catheter
shaft. The Examiner rejected the claims as obvious. We have jurisdiction
under 35 U.S.C. § 6(b). We affirm.

Appeal 2011-001625
Application 11/470,488

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Statement of the Case
Background
“The invention relates to a catheter shaft and a method for making a
catheter shaft having a polymer coated inner lumen” (Spec. 1, ll. 20-21).
The Claims
Claims 1-7, 13, and 16-20 are on appeal. Claim 1 is representative
and reads as follows:
1. A catheter shaft, comprising:
an inner layer comprising a heat treated polymer,
said polymer being of a composition having the
characteristic of being water soluble prior to heat treating
and being not water soluble after heat treating, the
polymer comprising polyvinyl alcohol;
a reinforcing layer disposed over at least a portion
of the heat treated inner layer; and
an outer layer disposed over at least a portion of
the inner layer and at least a portion of the reinforcing
layer.

The issue

The Examiner rejected claims 1-7, 13, and 16-20 under 35 U.S.C. §
103(a) as obvious over Itou
1
and Handa
2
(Ans. 3-4).
The Examiner finds that “Itou discloses a catheter having an inner
layer, a reinforcing (i.e., support) layer, and an outer layer . . . [t]he
reinforcing layer includes a braid or a coil . . . and includes a tip segment
where the tip segment is free of the reinforcing layer” (Ans. 3). The
Examiner finds that “Handa discloses a catheter in the analogous art to Itou,

1
Itou et al., US 6,511,462 B1, issued Jan. 28, 2003.
2
Handa et al., US 4,301,803, issued Nov. 24, 1981.
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Application 11/470,488

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having a shaft with an inner layer comprising a heat treated polyvinyl
alcohol which was water soluble prior to heat treatment and is water
insoluble after a well-known process of heat treatment” (Ans. 3).
The Examiner finds it obvious to use “a polyvinyl alcohol polymer
being water insoluble after heat treating since Handa discloses that doing so
would be useful to form a fine tube insertable even into crooked and/or fine
blood vessels, having improved dry and wet tensile strength, and being
suitable to resist boiling water treatment or disinfection” (id. at 4).
Appellants contend that “[n]othing in the disclosure of Handa
indicates that the properties of the PVA, other than possibly initial water
solubility sufficient to allow drafting of the extrudate, are significant to the
initial formation of the hollow fiber or tube or to the insolubility of the
resulting acetalized PVA” (App. Br. 7).
Appellants contend that “Handa does not disclose a PVA which is
both soluble before heat treating and not soluble following heat treating” (id.
at 8). Appellants contend that “Handa does not inherently disclose that the
PVA employed has the characteristic recited in the independent claims” (i. at
9).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s conclusion that Itou and Handa render obvious a
catheter shaft comprising “an inner layer comprising a heat treated polymer,
said polymer being of a composition having the characteristic of being water
soluble prior to heat treating and being not water soluble after heat treating,
the polymer comprising polyvinyl alcohol” as required by claim 1?

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Findings of Fact
1. The Specification teaches that “where the inner polymer layer is
to be formed of polyvinyl alcohol . . . an aqueous coating solution including
. . . polyvinyl alcohol can be used. . . . [T]he mandrel can be dipped into the
solution, and withdrawn . . . [t]he coated mandrel is than passed through an
IR heat zone for drying and/or curing” (Spec. 7, ll. 6-11).
2. Itou teaches that:
base tube 4 is prepared by the ordinary method. As
described previously, it is possible for the base tube 4 to
include the reinforcing layer 41 and the low friction layer
43. The first linear member 51 and the second linear
member 52 are braided to form a mesh on the outer surface
of the base tube 4.

(Itou, col. 16, ll. 25-31.)
3. Figure 7 of Itou is reproduced below:

“FIG. 7 shows a manufacturing step of the catheter” (Itou, col. 5, l. 16).
4. Itou teaches that “a reinforcing layer 41 is formed on the outer
surface of the base tube 4 . . . [i]t is desirable for the reinforcing layer 41 to
be formed of a braided body constituted by a metal wire 42 or a metal ribbon
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. . . the reinforcing layer may be arranged between the resin layer 5 and the
outer layer 6” (Itou, col. 10, ll. 17-28).
5. Itou teaches that the “base tube 4 is made of a flexible material
including, for example, polyolefin such as . . . ethylene-vinyl acetate
copolymer . . . polyurethane, polyvinyl chloride” (Itou, col. 9, ll. 49-54).
6. Itou teaches that the “resin material of the first linear member
51 and the second linear member 52 includes, for example . . . high tensile
polyvinyl alcohol” (Itou, col. 8, ll. 1-9).
7. Handa teaches that “materials having a Young‟s modulus
within the above-mentioned range can be used for the production of a fine
tube as the catheter. Among these materials, acetalized polyvinyl alcohol
(polyvinyl alcohol will be abbreviated to „PVA‟ hereinafter) is most
preferred as the material of the fine tube” (Handa, col. 4, ll. 30-35).
8. Handa teaches that:
A PVA hollow fiber or tube is prepared from an
aqueous solution of PVA having a concentration of about
15% according to the wet method using an aqueous solution
of sodium sulfate as a coagulating bath while drafting the
extrudate. The PVA hollow fiber or tube is subjected to the
dry heat treatment at 200° to 240° C. for several minutes and
formalized for 40 to 60 minutes at 50° to 70° C. in a
formalizing bath containing 150 to 250 g/l of sodium sulfate,
150 to 250 g/l of sulfuric acid and 40 to 60 g/l of
formaldehyde. The degree of formalization is in the range of
30 to 40 mol % in the so obtained PVA hollow fiber or tube.

(Handa, col. 4, ll. 57-68.)
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9. Handa teaches that the “acetalized PVA catheter has an
advantage that it can sufficiently resist the boiling water treatment for
disinfection” (Handa, col. 5, ll. 9-11).
10. Handa teaches that the “acetalized PVA catheter . . . is excellent
in both the dry tensile strength and the wet tensile strength. Accordingly, the
thickness can be decreased though the diameter is very small and the
catheter has such an appropriate flexibility that it is not readily bent in
water” (Handa, col. 5, ll. 1-7).
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
“If a person of ordinary skill can implement a predictable variation, §
103 likely bars its patentability.” Id. at 417. As noted by the Court in KSR,
“[a] person of ordinary skill is also a person of ordinary creativity, not an
automaton.” 550 U.S. at 421.
Analysis
Itou teaches that an inner layer of a catheter shaft “4 is prepared by the
ordinary method. . . . it is possible for the base tube 4 to include the
reinforcing layer 41 and the low friction layer 43. The first linear member 51
and the second linear member 52 are braided to form a mesh on the outer
surface of the base tube 4” (Itou, col. 16, ll. 25-31; FF 2). Itou teaches that
the “the reinforcing layer may be arranged between the resin layer 5 and the
outer layer 6” (Itou, col. 10, ll. 17-28; FF 4).
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The Examiner acknowledges that Itou does not teach a polyvinyl
alcohol inner layer (Ans. 3).
Handa teaches “production of a fine tube as the catheter. Among these
materials, acetalized polyvinyl alcohol (polyvinyl alcohol will be
abbreviated to „PVA‟ hereinafter) is most preferred as the material of the
fine tube” (Handa, col. 4, ll. 30-35; FF 7). Handa teaches that initially the
polyvinyl alcohol polymer is in an aqueous phase and water soluble (FF 8)
and that following heat and chemical treatment the “acetalized PVA catheter
has an advantage that it can sufficiently resist the boiling water treatment for
disinfection” (Handa, col. 5, ll. 9-11; FF 9).
Applying the KSR standard of obviousness to the findings of fact, we
agree with the Examiner that an ordinary artisan would have reasonably
found it obvious to produce the inner tube of Itou‟s catheter using the
polyvinyl alcohol polymer of Handa since Handa teaches that this polymer
has excellent tensile strength, appropriate flexibility and can be easily
sterilized in boiling water (FF 9-10). Such a combination is merely a
“predictable use of prior art elements according to their established
functions.” KSR, 550 U.S. at 417.
Appellants contend that “[n]othing in the disclosure of Handa
indicates that the properties of the PVA, other than possibly initial water
solubility sufficient to allow drafting of the extrudate, are significant to the
initial formation of the hollow fiber or tube or to the insolubility of the
resulting acetalized PVA” (App. Br. 7).
We are not persuaded. Handa expressly teaches that the “acetalized
PVA catheter . . . is excellent in both the dry tensile strength and the wet
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tensile strength. Accordingly, the thickness can be decreased though the
diameter is very small and the catheter has such an appropriate flexibility
that it is not readily bent in water” (Handa, col. 5, ll. 1-7; FF 10). Handa
continues that “this catheter is preferably used” (Handa, col. 5, ll. 7-8).
These are express teachings which motivate the use of the polyvinyl alcohol
polymer for use as the base catheter shaft of Itou.
Appellants contend that “Handa does not disclose a PVA which is
both soluble before heat treating and not soluble following heat treating”
(App. Br. 8).
We are not persuaded. Handa teaches preparation of a PVA tube
“from an aqueous solution of PVA” (Handa, col. 4, ll. 57-58; FF 8) teaching
that the PVA was soluble prior to heat treating. Handa then teaches that the
“PVA hollow fiber or tube is subjected to the dry heat treatment at 200° to
240° C. for several minutes and formalized for 40 to 60 minutes at 50° to
70° C. in a formalizing bath” (Handa, col. 4, ll. 61-64; FF 8). Handa teaches
that following the heat and formalizing treatment, the PVA can resist boiling
water (FF 9), demonstrating that it was not soluble following the heat
treatment step.
Appellants contend that following “the acetalization reaction, the
acetalized polymer is no longer the PVA which was water soluble prior to
heating” (App. Br. 8).
This seems to be the crux of Appellants argument, that the PVA of
Handa is no longer PVA after the acetalization reaction. We are not
persuaded because claim 1 expressly requires “an inner layer comprising a
heat treated polymer . . . the polymer comprising polyvinyl alcohol” (Claim
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1). However, the transitional term “comprising” is “inclusive or open-
ended and does not exclude additional, unrecited elements or method steps.”
Georgia-Pacific Corp. v. United States Gypsum Co., 195 F.3d 1322, 1327,
(Fed. Cir. 1999). Therefore, applying the broadest reasonable interpretation
to Appellants‟ use of the term “comprising” in Claim 1 results in a claim
which can encompass acetalized polyvinyl alcohol polymers which further
comprise acetal groups. Handa expressly identifies the polymer as PVA
before and after formalizing treatment (FF 8-10). Appellants‟ Claim 1 does
not exclude either the additional step of formalizing taught by Handa nor
does Claim 1 exclude the modified polyvinyl alcohol of Handa due to the
use of “comprising.”
Appellants contend that “Handa does not inherently disclose that the
PVA employed has the characteristic recited in the independent claims”
(App. Br. 9).
We are not persuaded. Handa expressly discloses that the PVA has
the characteristics required by Claim 1, and the Examiner need not rely upon
the inherency doctrine here where the evidence demonstrates the properties
of Handa‟s PVA. Handa expressly teaches that the PVA was aqueous prior
to heat treating (FF 8) and was not water soluble after heat treatment, even in
boiling water (FF 9), which expressly satisfies the functional requirements of
Claim 1.
Conclusion of Law
The evidence of record supports the Examiner‟s conclusion that Itou
and Handa render obvious a catheter shaft comprising “an inner layer
comprising a heat treated polymer, said polymer being of a composition
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having the characteristic of being water soluble prior to heat treating and
being not water soluble after heat treating, the polymer comprising polyvinyl
alcohol” as required by claim 1.
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C. §
103(a) as obvious over Itou and Handa. Pursuant to 37 C.F.R. § 41.37(c)(1),
we also affirm the rejection of claims 2-7, 13, and 16-20 as these claims
were not argued separately.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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