Ex Parte Schewe et al

Board of Patent Appeals and Interferences

Oct 19, 2009

10617428 (B.P.A.I. Oct. 19, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte SCOTT SCHEWE, VICTOR SCHONELE, and JAN WEBER
____________

Appeal 2009-003316
Application 10/617,428
Technology Center 1700
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Decided: October 19, 2009
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Before JEFFREY T. SMITH, BEVERLY A. FRANKLIN, and
JEFFREY B. ROBERTSON, Administrative Patent Judges.

ROBERTSON, Administrative Patent Judge.

DECISION ON APPEAL
Appeal 2009-003316
Application 10/617,428

STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’s
rejection of claims 23-25 and 43-45.1 (Appeal Brief filed September 7,
2007, hereinafter “App. Br.,” 2). We have jurisdiction pursuant to 35 U.S.C.
§ 6(b).
We AFFIRM-IN-PART.
THE INVENTION
Appellants describe a method of forming a polymeric tubing segment
or parison for a medical device or medical device balloon. Claims 23 and
43, reproduced below, are representative of the subject matter on appeal.
23. A method of making a parison for forming a medical
device balloon in which portions of the parison are slated to
form cone and waist portions of the balloon and a portion is
slated to form the balloon body, the method comprising a step
of extruding polymeric material to form a tube, and forming the
parison having said slated portions from the tube, wherein the
extruding step is controlled to provide the extruded tube with a
varying longitudinal orientation, such that the slated parison
formed therefrom has variation providing a lower or higher
orientation for the cone and waist slated portions of the parison
relative to the portion slated to form the balloon body.

43. A method of forming a polymeric tubing segment for a
medical device comprising extruding a tube of polymeric
material through a die and cooling the extruded tubing by
drawing it through a cooling region spaced at a gap length from
the die to the cooling bath, wherein the drawing rate, or the gap
length, or the cooling rate of the cooling region, or any
combination thereof, is altered along the length of the segment,

1 Claims 1-9, 13, 29, and 38-42 have been canceled. (Amendment After
Final filed April 3, 2007). Claims 10-12, 14-22, 26-28, and 30-37 have been
allowed. (Advisory Action mailed April 23, 2007).
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Application 10/617,428

whereby the segment is formed with at least two regions along
the length thereof, a first of said regions and a second of said
regions having different elongation at yield properties relative
to each other and wherein
said alteration of the drawing rate, or the gap length, or
the cooling rate of the cooling region, or combination thereof, is
selected on the basis of the elongation at yield properties of said
first and second regions.

THE REJECTIONS
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Pepin US 5,614,136 Mar. 25, 1997
Chen US 6,905,743 B1 Jun. 14, 2005

The Examiner separately rejected claims 23-25 and 43-45 under 35
U.S.C. § 102(b) as being anticipated by Pepin as evidenced by Chen.

ISSUES
Have Appellants shown that the Examiner reversibly erred in finding
that Pepin discloses a method of making a parison as recited in claim 23?
Have Appellants shown that the Examiner reversibly erred in finding
that Pepsin discloses the method of forming the polymeric tubing segment
recited in claim 43?
Have Appellants shown that the Examiner reversibly erred in finding
that the difference in elongation at yield value recited in claim 44 is inherent
to Pepin’s method?

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Appeal 2009-003316
Application 10/617,428

FINDINGS OF FACT
The record supports the following findings of fact (FF) by a
preponderance of the evidence.
1. The Examiner found that Pepin discloses the claimed process of
forming a polymeric tube segment by extruding a polymeric tube,
drawing/puling the tube through a cooling bath, and
altering/varying the drawing rate to change dimensions in at least
two regions or predetermined locations along the tube.
(Examiner’s Answer entered August 1, 2008, hereinafter “Ans.,”
3-4).
2. The Examiner found that the changes in drawing/pulling rates of
the polymeric material in Pepin:
“inherently yield different orientations of the material
within the article at the different locations. The examiner
notes and submits that this different orientation inherently
yields ‘different stabilization’ properties (e.g. elongation at
yield properties) as is also evidenced by Chen et al. at col.
5, lines 35-40. Accordingly, the examiner submits that the
choice to change the dimensions in Pepin et al. by
adjusting the drawing/pulling rate, also changes the
‘longitudinal stabilization’ properties (e.g. elongation at
yield properties) of the article in the same locations the
dimensions are changed.”
(Ans. 10-11).
3. Figure 3 of Appellants’ Specification is reproduced below:
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Application 10/617,428

Figure 3 depicts a tubing segment 50 for a balloon parison with varied
orientation over the length having minimum regions 52 and 60, transition
regions 54 and 58, and central region 56. (Spec. 7:28 – 8:4).
4. Figure 7 of Pepin is reproduced below:

Figure 7 depicts a tubular member 60 with varying dimensional
characteristics with minimum regions 32, transition regions 31, and
central region 30. (See Col. 7, ll. 43-59).
5. Pepin states: “[b]y using the novel process of the present invention,
dimensionally variable tubular members may be formed to desired
specifications to meet required operational and performance
characteristics without sacrificing the structural integrity of the
tubular member.” (Col. 7, ll. 15-19).

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Application 10/617,428

PRINCIPLES OF LAW
“Anticipation requires that every limitation of the claim in issue be
disclosed, either expressly or under principles of inherency, in a single prior
art reference.” Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868
F.2d 1251, 1255-56 (Fed. Cir. 1989).

ANALYSIS
Appellants have grouped certain claims subject to each of the two
grounds of rejection separately. However, Appellants rely on similar
arguments for claims 23-25. Accordingly, we confine our discussion to
appealed claims 23, 24, 43, and 44, which contain claim limitations
representative of the arguments made by Appellants pursuant to 37 C.F.R. §
41.37(c)(1)(vii).2
Claim 23
Appellants do not dispute the Examiner’s finding that the changes in
drawing rate disclosed in Pepin inherently result in different orientations for
the resulting polymeric material. (See App. Br. 5). Rather, Appellants
contend that although a balloon parison starts out as an extruded tube, once
the different regions are slated the tubing segment is a parison that is
qualitatively differentiated from tubing extrusions intended for other
purposes such as catheter shaft or tip sections. (App. Br. 6-7). Appellants
argue that the claim does not read on extruded tubing with different
orientation along its length. (App. Br. 7). Appellants contend that Pepin

2 Only those arguments actually made by Appellants have been considered in
this decision. Arguments which Appellants could have made but chose not
to make have not been considered and are deemed to be waived. See 37
C.F.R. § 41.37(c)(1)(vii) (2007).
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does not disclose forming balloon parisons, arguing that Pepin’s Figure 7
shows the formation of soft catheter tips. (App. Br. 8-9, FF 4). Appellants
admit that Pepin discloses slated portions, but argue that the slated portions
disclosed by Pepin do not satisfy the recitations of claim 23, because the
slated portions have “nothing to do with balloons or balloon segments.”
(App. Br. 9).
Appellants have not directed our attention to any persuasive evidence
that the recited method of forming a slated parison is different than Pepin’s
method. Specifically, Appellants’ claims do not place any particular
limitations on the extent of longitudinal orientation or variation of wall
thicknesses in forming the cone and waist slated portions of the parison as
compared to the longitudinal orientation in the method of Pepin. Thus,
Appellants have not demonstrated that referring to the extruded tube as a
“parison” having “cone and waist slated portions” necessarily imparts any
patentable distinction between the method of the present claims and the
method of forming the slated extruded tubes of Pepin. Moreover, regarding
Figure 7 of Pepin, Appellants have not presented any persuasive evidence
demonstrating any qualitative structural differences between the extruded
tube with varying longitudinal orientation produced by Pepin’s method as
depicted in Figure 7 and the balloon parison produced by Appellants’
method as depicted in Appellants’ Figure 3. (See FF 3 and 4).
Regarding claim 24, Appellants contend that Pepin does not disclose
the extrusion/slating relationship recited in the claim. (App. Br. 9-10).
However, Appellants have failed to point out with any specificity why the
Examiner’s rationale regarding the varying the drawing/pulling rate is in
error. (Ans. 4). Therefore, we are not persuaded by Appellants’ argument.
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Claim 43
Appellants do not dispute that Pepin shows a process for extruding
polymeric tubing where the drawing rate is altered to provide at least two
regions having different elongation at yield properties. (App. Br. 11-12).
Rather, Appellants contend that Pepin does not teach selecting the drawing
rate based on the elongation at yield properties. (App. Br. 12). Appellants
argue teach selecting the drawing rate based on the elongation at yield
properties is a choice criterion and Pepin does not show that there was a
desire to use a known parameter as a proxy for the elongation property.
(App. Br. 12-13). Appellants additionally contend that different elongation
properties, if produced, would be a result of the alteration not the basis of the
alteration. (Reply Brief filed September 16, 2008, 5).
We agree with the Examiner, that Pepin describes a choice to change
dimensions by adjusting the drawing/pulling rates, which changes the
elongation at yield properties in the same locations. (Ans. 10-11). Claim 43
does not recite any particular variation of elongation at yield properties. In
addition, Appellants do not specifically address the Examiner’s position that
Pepin discloses that varying the drawing rate effects the dimensional
characteristics, which in turn affects other operational and performance
characteristics inclusive of elongation properties. (Ans. 4-5 and 10-11; FF
5). Therefore, Appellants’ arguments are not persuasive.
Claim 44
Regarding claim 44, we agree with Appellants that Pepin does not
disclose the specific variation in elongation at yield recited in the claim.
(App. Br. 13). Accordingly we cannot sustain the Examiner’s rejection of
claims 44 and 45 under 35 U.S.C. §102(b).
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CONCLUSION
Appellants have failed to demonstrate that the Examiner reversibly
erred in finding that Pepin discloses a method of making a parison as recited
in claim 23.
Appellants have failed to demonstrate that the Examiner reversibly
erred in finding that Pepsin discloses the method of forming the polymeric
tubing segment recited in claim 43.
Appellants have demonstrated that the Examiner reversibly erred in
finding that the difference in elongation at yield value recited in claim 44 is
inherent to Pepin’s method.

ORDER
We affirm the Examiner’s decision rejecting claims 23-25 and 43
under 35 U.S.C. § 102(b) as being anticipated by Pepin as evidenced by
Chen.
We reverse the Examiner’s decision rejecting claims 44 and 45 under
35 U.S.C. § 102(b) as being anticipated by Pepin as evidenced by Chen
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. §1.136(a)(1)(v).
AFFIRMED-IN-PART

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