Ex Parte Pallazza

Patent Trial and Appeal Board

May 23, 2016

13495247 (P.T.A.B. May. 23, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/495,247 06/13/2012
11050 7590 05/25/2016
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
FIRST NAMED INVENTOR
Stefan M. Pallazza
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
2001.1386102 8530
EXAMINER
HOUSTON, ELIZABETH
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
05/25/2016 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
BSC.USPTO@stwiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte STEFAN M. PALLAZZA
Appeal2014-001088
Application 13/495,247 1
Technology Center 3700
Before THOMAS F. SMEGAL, LISA M. GUIJT, and
MARK A. GEIER, Administrative Patent Judges.
SMEGAL, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Stefan M. Pallazza (Appellant) seeks our review under 35 U.S.C.
§ 134 of the Examiner's final rejection of claims 1-16.2 We have
jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
1 According to Appellant, the real party in interest is Boston Scientific
Scimed, Inc. Appeal Br. 3.
2 Claims 17-20 have been withdrawn. See Non-Final Action mailed Dec. 6,
2012.
Appeal2014-001088
Application 13/495,247
CLAIMED SUBJECT MATTER
Claim 1, the sole independent claim, is reproduced below and
illustrates the claimed subject matter, with disputed limitations emphasized.
1. A catheter assembly comprising:
at least one catheter shaft having a proximal end and a
distal end; and
a multilayer expandable medical balloon, the multilayer
expandable medical balloon comprising at least one continuous
inner layer, the inner layer having an inner surface and an outer
surface, and at least one outer layer, the at least one outer layer
comprising a cavity which extends through the at least one outer
layer, the at least one continuous inner layer comprising a
polymer material having a first compliance and the at least one
outer layer comprising a polymer material having a second
compliance that is less than the first, the balloon having at least
one unexpanded state and at least one expanded state, in the
expanded state during use, the at least one continuous inner layer
is exposed at the cavity.
REJECTIONS
The following Examiner's rejections are before us for review3.
1. Claims 1-5, 7, 13, and 16 are rejected under 35 U.S.C. § 102(b) as
anticipated by Crocker (US 2003/0028211 Al, pub. Feb. 6, 2003).
3 In a Non-Final Action mailed December 6, 2012, the Examiner rejected
claims 1-12 and 14--16 on the ground of nonstatutory obviousness-type
double patenting over claims 1, 4--7, 10, 11, and 15 of U.S. Patent 8,216,267
and Davidson, and claim 13 on the ground of nonstatutory obviousness-type
double patenting over claims 1, 4--7, 10, 11, and 15 of U.S. Patent
8,216,267, Davidson, and Williams. See Non-Final Act. 3---6; see also
Amendment 6-7, dated Feb. 4, 2013. Although these rejections appear not
to have been either withdrawn or overcome, they are not restated in the Final
Action mailed February 15, 2013, from which this appeal is taken.
Therefore, they are not before us for review.
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Appeal2014-001088
Application 13/495,247
2. Claims 1-3, 14, and 16 are rejected under 35 U.S.C. § 102(b) as
anticipated by Ben-Muvhar (WO 2005/041810 A2, pub. May 12, 2005).
3. Claims 6, 8, and 12 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Crocker and Dusbabek (US 2001/0007082 Al, pub. July
5,2001).
4. Claim 9 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Crocker and Gahara (US 4,950,239, iss. Aug. 21, 1990).
5. Claim 10 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Crocker, Dusbabek, and Gahara.
6. Claim 11 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Crocker and Coyle (US 2004/0039409 Al, pub. Feb. 26, 2004).
7. Claim 15 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Ben-Muvhar and Davidson (US 2004/0267352 Al, pub. Dec. 30, 2004).
ANALYSIS
Anticipation of claims 1-5, 7, 13, and 16 by Crocker
We are persuaded by Appellant's arguments that the Examiner fails to
establish a prima facie showing of anticipation in rejecting claims 1-5, 7, 13,
and 16 over Crocker. See Appeal Br. 9-11 and Reply Br. 2--4.
The Examiner finds that Crocker anticipates independent claim 1 by
disclosing, inter alia, an inner layer 18 having a first compliance and an
outer layer (expansion limiting bands) 40 having a second compliance less
than the first compliance, where "the inner layer extends through the
proximal and distal open ends (the at least one cavity [which extends
through the at least one outer layer]) in the at least one expanded state (and
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Appeal2014-001088
Application 13/495,247
the unexpanded state), exposing the inner layer at the cavity." Final Act. 3
(citing Crocker paras. 42, 46).
In contesting the rejection, Appellant submits that "the expansion
limiting bands disclosed by Crocker [] do not form a cavity within the
meaning of the present application," because "[ c ]laim 1 specifically recites
that the cavity extends through the outer layer exposing the underlying inner
layer at the cavity," which "makes clear ... that the cavity (as claimed)
provides a clear structural limitation ( e. g., it must extend through the outer
layer etc.) that is simply not shown or described in the Crocker[] reference."
Appeal Br. 9-11 (emphasis omitted). Thus, Appellant contends that Crocker
"simply cannot be interpreted to have a cavity extending through the
expansion limiting band and exposing the underlying balloon layer." Id. at
11.
The Examiner responds that "the open ends leading into the lumen of
the 'bands' can clearly be considered a cavity (i.e. 'an unfilled space within
a mass')," again reasoning that "the outer layer (one or more of the bands
40) extends over the inner layer (balloon 18) without covering the entire
surface of the inner layer." Ans. 4.
Appellant replies by explaining that the Examiner's definition of
cavity "does not support the Examiner's position that the expansion limiting
bands of the [Crocker] balloon comprise a cavity, i.e. an unfilled space
within the mass of the expansion limiting bands," because "the lumen of the
expansion limiting[] [bands] is entirely covered by the inner layer that forms
the balloon." Reply Br. 3. As Appellant also explains, for that reason "the
expansion limiting bands cannot be found to have a cavity which exposes
the underlayer of the balloon." Id. We agree with Appellant that Crocker
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Appeal2014-001088
Application 13/495,247
does not disclose a cavity as recited by claim 1 and find the determination
made by the Examiner to be an arbitrary (and therefore unreasonable)
interpretation of the disclosure in Crocker.
[U]nless a reference discloses within the four comers of the
document not only all of the limitations claimed but also all of
the limitations arranged or combined in the same way as recited
in the claim, it cannot be said to prove prior invention of the thing
claimed and, thus, cannot anticipate under 35 U.S.C. § 102.
Net MoneyIN, Inc., v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).
For the foregoing reasons, we do not sustain the Examiner's rejection
of independent claim 1 and claims 2-5, 7, 13, and 16 depending therefrom
as anticipated by Crocker.
Anticipation of claims 1-3, 14, and 16 by Ben-Muvhar
We are persuaded by Appellant's arguments that the Examiner fails to
establish a prima facie showing of anticipation in rejecting claims 1-3, 14,
and 16 over Ben-Muvhar. See Appeal Br. 12-14 and Reply Br. 5-10.
The Examiner finds that Ben-Muvhar anticipates independent claim 1
by disclosing, inter alia, multilayer balloon 50 including "at least one
continuous inner layer 52 ... and at least one outer layer 54 comprising a
cavity which extends through the outer layer, the inner layer comprising a
polymer material more compliant [than] the outer layer," where "the outer
layer of the inner layer is exposed at the cavity when the balloon is in the
expanded state." Final Act. 4 (citing Ben-Muvhar, Figs. 7 and 8, pages 10,
11. 11-13 and 13, 11. 7-16).
Appellant contends that Ben-Muvhar merely discloses "a single layer
balloon" having a portion that "can be both inverted into the interior of the
balloon and radially protruded to the exterior of the balloon as illustrated in
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Application 13/495,247
FIG. 8." Appeal Br. 12. Appellant also submits that "[i]n the expanded
state, the Ben-Muvhar et al. balloon is [still] clearly a single layer." Id. at
13.
The Examiner responds that "[i]n the collapsed configuration as
depicted in Fig 8, [each of] the inner layer and the outer layer of Ben-
Muvhar can clearly be considered a 'thickness' that is 'lying over or under
another', forming a multilayer balloon as claimed," reasoning that
even though there is space depicted between the inner layer and
the outer layer of Ben-Muvhar, one of ordinary skill in the art
would understand that [] the air would be removed such that the
outer layer would be collapsed directly onto the inner layer to
reduce the profile and facilitate passage through the vasculature. 4
Ans. 5-6 (emphases omitted).
However, Appellant correctly determines that Ben-Muvhar "fails to
disclose or suggest that there is a cavity in the outer layer of the balloon that
exposes an inner layer in an inflated state," because Ben-Muvhar's "balloon
in an expanded state is still a single layer balloon, not a multilayer balloon as
recited by claim 1." Reply Br. 7. Thus, we agree with Appellant that Ben-
Muvhar does not disclose a multilayered balloon with a cavity in an outer
layer through which an inner layer is exposed when the balloon is in an
inflated state, as recited by claim 1 and find the determination made by the
Examiner to be an arbitrary (and therefore unreasonable) interpretation of
the disclosure in Ben-Muvhar. See Net Money!N, 545 F.3d at 1371.
4The Examiner's finding appears to be that the inverted portion of Ben-
Muvhar' s balloon is a separate inner layer because of having a "thickness."
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Application 13/495,247
For the foregoing reasons, we do not sustain the Examiner's rejection
of independent claim 1 and claims 2-3, 14, and 16 depending therefrom as
anticipated by Ben-Muvhar.
Obviousness of claims 6, 8, and 12 over Crocker and Dusbabek; of
claim 9 over Crocker and Gahara; of claim 10 over Crocker, Dusbabek and
Gahara; of claim 11 over Crocker and Coyle; and of claim 15 over Ben-
Muvhar and Davidson
Regarding the claims 1, 8-12, and 15, each of the Examiner's
rejections is based on the same unsupported findings discussed above with
respect to the disclosure of Crocker or Ben-Muvhar. See generally Final
Act. 5-8. The addition ofDusbabek, Gahara, Coyle, and/or Davidson does
not remedy the deficiencies of either Crocker or Ben-Muvhar, as discussed
supra.
Accordingly, for similar reasons as discussed above for claim 1, we
do not sustain the Examiner's decisions rejecting claims 6, 8, and 12 over
Crocker and Dusbabek; claim 9 over Crocker and Gahara; claim 10 over
Crocker, Dusbabek, and Gahara; claim 11 over Crocker and Coyle; and
claim 15 over Ben-Muvhar and Davidson.
DECISION
The Examiner's prior-art rejections are reversed.
REVERSED
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