Ex Parte Bertolino et al

Board of Patent Appeals and Interferences

May 31, 2011

11203318 (B.P.A.I. May. 31, 2011)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
11/203,318 08/12/2005 William Bertolino 1001.2326103 1303
11050 7590 05/31/2011
SEAGER, TUFTE & WICKHEM, LLC
1221 Nicollet Avenue
Suite 800
Minneapolis, MN 55403
EXAMINER
MIGGINS, MICHAEL C
ART UNIT PAPER NUMBER
1782
MAIL DATE DELIVERY MODE
05/31/2011 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 WILLIAM BERTOLINO,
ANDREW J. CAMPBELL, RALPH BARRY, JR.,
NIL CHAY, GERALDO CARRION,
and SHAHEN ANDONIAN
____________

Appeal 2010-001059
Application 11/203,318
Technology Center 1700
____________

Before CHUNG K. PAK, CATHERINE Q. TIMM, and MARK NAGUMO,
Administrative Patent Judges.

PAK, Administrative Patent Judge.

DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’s
refusal to allow claims 39 through 48, all of the claims pending in the above-
identified application.1 We have jurisdiction under 35 U.S.C. § 6.

1 See Appeal Brief (“App. Br.”) filed February 16, 2009, 3-4; and
Examiner’s Answer (“Ans.”) filed June 24, 2009, 2.

Appeal 2010-001059
Application 11/203,318

2
STATEMENT OF THE CASE
The subject matter on appeal is directed to “medical balloons, such as
dilation balloons and catheters using such balloons” (Spec. 1, ll. 8-9 and
Spec. 2, ll. 10-11). These medical balloons “include a block copolymer
having a cylindrically-shaped region exhibiting a birefringence pattern of
substantially parallel lines before and after an exposure to sterilization
temperatures,” e.g., temperatures between about 32oC and about 60oC (Spec.
3, ll. 18-19 and 25-28 and claim 39).
The medical balloons can be formed by radially expanding a single
layer or multilayer tube (parison) made of, inter alia, a block copolymer
having hard and soft segments, such as a polyether-ester elastomer (e.g.,
Arnitel® EM740 from DSM Engineering Plastics), a polyester elastomer
(e.g., Hytrel® from E.I. du Pont de Nemours and Co.), or a polyether block
amide (e.g., Pebax® from Atofina), in a mold (Spec. 3, ll. 7-15 and Spec. 7,
ll. 2-8). The tube (parison) is first expanded radially in the mold while
allowing the ends of the tube to move axially in response to the radial
expansion (due to no restriction or cramping) and then axially orienting the
material of the tube. (See Spec. 2, ll. 15-24 and Spec. 3, ll. 7-8).
Alternatively, the tube is first axially drawn and is expanded radially in a
mold while allowing the ends of the tube to move axially in response to said
radial expansion. (See Id.) According to page 3, lines 1-9, of the
Specification,
Expanding the tube can include heating the tube, e.g., to
a temperature about equal to or greater than a glass transition
temperature of a material of the tube. The tube can be
expanded to an expanded diameter of the balloon being made.
In certain embodiments, the tube can be expanded to an
Appeal 2010-001059
Application 11/203,318

3
expanded diameter about 1 to about 15 times, e.g., about 5 to
about 9 times, larger than an unexpanded diameter of the tube,
e.g., by introducing a gas into the tube. Expanding the tube can
include simultaneously heating and pressurizing the tube.
Expanding the tube can include positioning the tube into a
mold, and simultaneously heating and pressurizing the tube.
Expanding the tube can include contacting the tube with a
liquid, e.g., one including water. [(See also Figs. 4A, 4B, and
4C.)]
The mold was heated to a temperature greater than the glass transition
temperature of the tube material (a block copolymer, such as the polyether-
ester elastomer identified as “Arnitel®”), e.g., about 110-115oC and the tube
exemplified was heated to balloon forming temperatures about equal to or
greater than a glass transition temperature of the tube material, e.g., about
45-50oC. (Spec. 12, ll. 7-11). The Specification states that the birefringence
patterns that are non-uniform and not straight are formed when the axial
movement of the tube is restricted during blowing, i.e., radial expansion of
the tube, as evidenced by Figures 2B and 2C (Spec. 13, ll. 8-12).
Details of the appealed subject matter are recited in representative
claim 392 reproduced from the Claims Appendix to the Appeal Brief as
shown below:
39. A medical balloon comprising a block copolymer having a
cylindrically-shaped region exhibiting a birefringence pattern of
substantially parallel lines before and after an exposure to temperatures of
about 32° C to about 60° C. [(Emphasis added.)]

2 Appellants have not separately argued the claims on appeal (App. Br. 4-7).
Therefore, for purposes of this appeal, we select claim 39 as representative
of the claims on appeal and decide the propriety of the Examiner’s §102(b)
rejection set forth in the Answer based on this claim alone in accordance
with 37 C.F.R. § 41.37(c)(1)(vii) .

Appeal 2010-001059
Application 11/203,318

4

As evidence of unpatentability of the claimed subject matter, the
Examiner relies on the following sole prior art reference at page 2 of the
Answer:
Ishida US 5,879,369 Mar. 9, 1999
Appellants seek review of the Examiner’s rejection of claims 39
through 47 under 35 U.S.C. § 102(b) as anticipated by the disclosure of
Ishida (App. Br. 4 and Ans. 3).
PRINCIPLES OF LAW
As our reviewing court stated in In re Schreiber, 128 F.3d 1473, 1478
(Fed. Cir. 1997):
A patent applicant is free to recite features of an apparatus
either structurally or functionally. See In re Swinehart, [58
C.C.P.A. 1027], 439 F.2d 210, [212, 169 USPQ 226, 228]
(CCPA 1971) (“[T]here is nothing intrinsically wrong with
[defining something by what it does rather than what it is] in
drafting patent claims.”). Yet, choosing to define an element
functionally, i.e., by what it does, carries with it a risk. As our
predecessor court stated in Swinehart, 439 F.2d at 213, [169
USPQ at 228]:

where the Patent Office has reason to believe that
a functional limitation asserted to be critical for
establishing novelty in the claimed subject matter
may, in fact, be an inherent characteristic of the
prior art, it possesses the authority to require the
applicant to prove that the subject matter shown to
be in the prior art does not possess the
characteristic relied on. [(Emphasis added.)]

The “reason to believe” enunciated in Schreiber, according to In re Best,
562 F.2d 1252, 1255 (CCPA 1977), can arise where “the claimed and prior
Appeal 2010-001059
Application 11/203,318

5
art products are identical or substantially identical, or are produced by
identical or substantially identical processes.” As explained in Best,
562 F.2d at 1255:
Where…the claimed and prior art products are identical or
substantially identical, or are produced by identical or
substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily
or inherently possess the characteristics of his claimed product.
[citation omitted] Whether the rejection is based on
“inherency” under 35 U.S.C. 102, on “prima facie obviousness”
under 35 U.S.C. 103, jointly or alternatively, the burden of
proof is the same, and its fairness is evidenced by the PTO’s
inability to manufacture products or to obtain and compare
prior art products.

RELEVANT FACTUAL FINDINGS, ISSUE, ANALYSIS, AND
CONCLUSION
Appellants do not dispute the Examiner’s finding that Ishida describes
a medical balloon comprising a block copolymer having a cylindrically-
shaped region. (Compare Ans. 3 with App. Br. 4-7; see also Ishida, col. 3,
ll. 37-65, col. 5, ll. 16-38.) Rather, Appellants contend that Ishida does not
teach either expressly or inherently the functionally defined characteristic
“exhibiting a birefringence pattern of substantially parallel lines before after
an exposure to temperature of about 32oC to about 60oC” recited in claim 39.
(See App. Br. 4.) On the other hand, the Examiner has found that the
medical balloon taught by Ishida is identical or substantially identical to that
claimed since Ishida teaches forming its medical balloon from a tube made
of the claimed block copolymer using a method similar to those described
and/or exemplified in the Specification. (See Ans. 3-4.) In this regard, the
Examiner has further found that the Specification relied upon by Appellants,
Appeal 2010-001059
Application 11/203,318

6
including Example 2 at pages 11-13 of the Specification, supports the
Examiner’s position and does not show that the medical balloon taught by
Ishida does not necessarily possess the claimed functionally defined
birefringence characteristic. (See Ans. 4-5.)
Thus, the disputed questions are: (1) Has the Examiner erred in
finding that there is reason to believe that the medical balloon taught by
Ishida has the functionally defined characteristic “exhibiting a birefringence
pattern of substantially parallel lines before and after an exposure to
temperature of about 32oC to about 60oC” recited in claim 39? And (2) Has
the Examiner erred in finding that Appellants have not shown that the
medical balloon taught by Ishida does not necessarily possess such
functionally defined characteristic? On this record, we answer these
questions in the negative.
As is apparent from Examples 1and 2 of Ishida, a two-layer tube
(parison) having a cover layer made of a block copolymer having an
aromatic polyester as the hard segment and an aliphatic polyether as the soft
segment (PELPRENE P150B) was formed, stretched or drawn in the axial
direction, inflated in a metal mold heated to 150 oC via introducing air and
then further inflated with nitrogen gas at 37 oC to form a medical balloon
comprising a block copolymer having a cylindrically-shaped region.
(Compare Ishida, col. 11, l. 45 to col. 12, l. 10, with Spec.11, l. 15 to Spec.
12, l. 31, Example 2.) Appellants do not question that the tube and mold
taught Ishida were heated at a temperature equal to greater than the glass
transition temperature of the material of the tube. (See App. Br. 4-7;
compare also the temperature employed in Examples 1 and 2 of Ishida
indicated supra with the temperatures employed in Appellants’ Example 2 at
Appeal 2010-001059
Application 11/203,318

7
Spec. 12, ll. 7-31.) This tube, like Appellants’ parison in Example 2, was
not drawn axially during its inflation (balloon formation) (Compare Ishida,
col. 11, l. 45 to col. 12, l. 10 with Spec. 12, ll. 2-4, Example 2.). Nor do
Examples 1 and 2 of Ishida require the ends of the tube to be mechanically
restricted or clamped during inflation, which is said to be responsible for not
forming the claimed functionally defined birefringence pattern. (Compare
Ishida, col. 11, l. 45 to col. 12, ll. l and Fig. 4 with Spec. 13, ll. 4-12,
Example 2.)
Given the similarities between the claimed and prior art medical
balloons and their methods of making the same, we concur with the
Examiner that there is reason to believe that the medical balloon taught by
Ishida has the functionally defined characteristic “exhibiting a birefringence
pattern of substantially parallel lines before and after an exposure to
temperature of about 32oC to about 60oC” recited in claim 39 within the
meaning of 35 U.S.C. § 102(b).
On this record, Appellants have not shown that the medical balloon
taught by Ishida does not necessarily possess such functionally defined
birefringence pattern. As indicated supra, the Specification relied upon by
Appellants, especially Example 2 at pages 11-13 of the Specification,
supports, rather than negates, the Examiner’s position.
Accordingly, based on the reasons set forth in the Answer and above,
we determine that the preponderance of evidence weighs most heavily in
favor of anticipation of the subject matter recited in claims 39 through 47
within the meaning of 35 U.S.C. § 102(b).
ORDER
In view of the foregoing, it is
Appeal 2010-001059
Application 11/203,318

8
ORDERED that the decision of the Examiner to reject claims 39
through 47 under 35 U.S.C. § 102(b) as anticipated by the disclosure of
Ishida is AFFIRMED; and
FURTHER ORDERED that 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)(iv).
AFFIRMED

cam