Ex Parte Kugler et al

Patent Trial and Appeal Board

Nov 29, 2018

13079179 (P.T.A.B. Nov. 29, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/079, 179 04/04/2011
11050 7590 12/03/2018
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
FIRST NAMED INVENTOR
Chad J. Kugler
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.
1001.3053102 9229
EXAMINER
OSINSKI, BRADLEY JAMES
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
12/03/2018 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
Ex parte CHAD J. KUGLER and ROBERT E. ATKINSON 1
Appeal2018-002667
Application 13/079, 179
Technology Center 3700
Before JOHN C. KERINS, LEE L. STEPINA, and
RICHARD H. MARSCHALL, Administrative Patent Judges.
STEPINA, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from the Examiner's
decision to reject claims 34--41 and 52-71. 2 We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.
1 The Appeal Brief indicates that Bridgepoint Medical, Incorporated, is the
real party in interest. Appeal Br. 3.
2 Claims 1-33 and 42-51 have been cancelled. Appeal Br. 20--21 (Claims
App.).
Appeal 2018-002667
Application 13/079, 179
CLAIMED SUBJECT MATTER
The claims are directed to an intravascular device having an exposed
balloon. Appeal Br. 20-21, 23 (Claims App.). Claim 34, reproduced
below, is illustrative of the claimed subject matter:
34. An intravascular device for treating a blood vessel having
a vascular wall, the vascular wall defining a vascular lumen, the
intravascular device including:
an elongate member defining a lumen extending distally
to a distal opening; and
a balloon located on a distal end region of the elongate
member, the balloon having a proximal end and a distal end;
wherein an exterior surface of the elongate member is
exposed between the proximal end of the balloon and the distal
end of the balloon;
wherein the balloon is configured to be inflated in the
vascular wall in opposing directions from the elongate member
to orient the distal opening toward the vascular lumen.
Id. at 20 ( emphases added).
REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Deaton
Makower '542
Makower '280
Flaherty
US 6,565,583 Bl
US 2003/0236542 Al
US 2004/0059280 Al
US 6,726,677 Bl
REJECTIONS
May 20, 2003
Dec. 25, 2003
Mar. 25, 2004
Apr. 27, 2004
(I) Claims 34--41 and 52-71 are rejected under 35 U.S.C. § 112,
first paragraph, as failing to comply with the written description
requirement.
2
Appeal 2018-002667
Application 13/079, 179
(II) Claims 34--41 and 52---68 are rejected under 35 U.S.C. § 103(a)
as unpatentable over Flaherty, Makower '542, and Deaton.
(III) Claims 69--71 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Flaherty, Deaton, Makower '542, and Makower '280.
OPINION
Rejection (I); Written Description
The Examiner finds that the recitation of "an exterior surface of the
elongate member [ ] exposed between the proximal and distal ends of the
balloon" in independent claim 34 is not supported by the original disclosure.
Final Act. 4. The Examiner makes similar findings with respect to
independent claims 52 and 62. Id. at 4--5. The Examiner determines that the
Specification does not describe this feature, Figures 12A-12D do not
support this feature because they may be interpreted as cross-sectional
views, and there is no evidence that Figures 12A-12D were intended to
depict a side view of the claimed device. 3 Id. at 14--16. The Examiner notes
that the Specification uses the term "schematic illustrations" to describe
Figures 12A-12D. Id. at 15-16 (citing Spec. ,r 22).
Appellants contend that Figures 12A-12D support the claim limitation
at issue because a person of ordinary skill in the art would understand that
these Figures depict a side view (rather than a cross-sectional view) of the
claimed device inasmuch as, in Figure 12D, only a portion of stylet 1230 is
shown, not its entire length as would be depicted in a cross-sectional view.
Appeal Br. 7-8. Appellants also point to Figures 3-5, 7 A-7D, 9A, and 9B
3 If Figures 12A-12D depict side views of the device, then Figures 12B-12D
depict an exposed surface of catheter 1220.
3
Appeal 2018-002667
Application 13/079, 179
as depicting an intravascular device in a side view rather than a cross-
sectional view and assert that this depiction is consistent with how Figures
12A-12D depict the device, namely, in a side view rather than a cross-
sectional view. Id. at 9-10.
In response, the Examiner finds that the Specification provides no
indication as to how Figures 12A-12D are to be interpreted, much less that
they are to be interpreted as depicting a side view, as asserted by Appellants.
Ans. 12-13.
Although we appreciate the Examiner's position that the Specification
lacks any explanation as to whether Figures 12A-12D depict a side view of
the claimed device or a cross-sectional view, in light of the depiction of
stylet 1230 in Figure 12D and guide wire 1210 in Figures 12B and 12C, we
agree with Appellants that Figures 12A-12D depict the device in side view. 4
In this regard, we understand Figures 12A-12D to provide a view of the
device inside a blood vessel similar to the depiction in Figure 7 A, where the
device inside the blood vessel is depicted in side view. Given that Figures
12A-12D are side views of the device, we agree with Appellants that these
Figures support the requirement in claims 34, 52, and 62 that the elongate
member/ catheter shaft be exposed between the proximal and distal ends of
the balloon. Accordingly, we do not sustain the rejection of claims 34, 52,
and 62 and their associated dependent claims as failing to comply with the
written description requirement.
4 Despite the reference to "schematic illustrations" describing Figures 12A-
12D in paragraph 22 of the Specification, these drawings include aspects of
a side view, and the exposed nature of the elongate member would be
discemable to a person of ordinary skill in the art.
4
Appeal 2018-002667
Application 13/079, 179
Rejection (II); Flaherty, Makower '542, and Deaton
The Examiner finds that Flaherty discloses many of the elements
required by independent claim 34, including a balloon configured to be
inflated to orient a distal opening toward a vascular lumen. Final Act. 5---6.
Appellants contend that Flaherty fails to disclose this limitation
because "[i]nflating the balloon of Flaherty does not appear to have any
effect upon (e.g., does not change) the orientation of the alleged distal
opening 144 (see also FIG. 6B vs. FIG. 6C) and in fact, inflating the balloon
is meant to provide support and maintain a position of the device of
Flaherty." Appeal Br. 15. Appellants assert that any orientation of the
opening taught by Flaherty is achieved by rotation of an elongate shaft, not
the inflation of a balloon. Id.
In response, the Examiner states:
As Applicant has not specifically disclosed in the specification
what causes the orientation of the distal opening, the examiner
has had to make an educated guess based upon the figures. The
examiner's best guess was that due to the inner wall 1204 being
thinner than the outer wall 1206, a balloon which is inflated will
cause the inner wall 1204 to deform a greater amount than the
outer wall 1206, such that the distal open will orient toward the
lumen 1208. Flaherty possesses a balloon which inflates equally
on opposite sides (figs 5A-5 C) such that it is capable of operating
as claimed. If this assumption is not how Applicant's invention
operates, then the claims do not appear enabled.
Ans. 14 (emphases added). Thus, based upon Appellants' Figures, the
Examiner determines that a balloon that inflates equally on opposite sides
qualifies as a balloon that is configured to orient a distal opening toward a
vascular lumen as recited in claim 34.
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Appeal 2018-002667
Application 13/079, 179
Appellants argue that "a balloon that is radially equally inflated on
opposite sides would not necessarily result in orienting a distal opening
toward a vascular lumen (i.e., the orienting of a distal opening toward a
vascular lumen when a balloon is inflated would not be inherent in view of
Flaherty and Makower)." Reply Br. 7.
A preponderance of the evidence does not support the Examiner's
finding that a balloon that inflates equally on two sides qualifies as one that
is configured to perform the "orient" function recited in claim 34. The
Examiner's reasoning is based on an assumption that "the inner wall 1204
[is] thinner than the outer wall 1206." Ans. 14. However, even assuming
for the purpose of argument that the Examiner's finding regarding the
relative thicknesses of walls 1204 and 1206 is correct, the Examiner does not
direct our attention to any evidence that inner wall 1204 provides less
resistance to deflection than does outer wall 1206. Further, as Appellants
point out (Reply Br. 6-7), Flaherty does not disclose performing an "orient"
function as recited in claim 34 via inflation of a balloon, and, indeed,
discloses merely stabilizing Flaherty's disclosed device via the balloon. See
Flaherty, 10: 14--17 ("[I]nflation of the balloon 132 stabilizes the catheter
130, and facilitates operation of the tissue penetrating element 134. That is,
the balloon 132 contacts the wall of blood vessel, and fills the lumen
therein."). Thus, the Examiner's finding that Flaherty's balloon is
configured to perform the "orient" function recited in claim 34 (Final Act. 5)
is based on unsupported speculation.
The Examiner relies on Makower '542 and Deaton, respectively, to
disclose (i) a balloon that is capable of being inflated within a vascular wall
and (ii) an elongate member that is exposed between the ends of the balloon.
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Appeal 2018-002667
Application 13/079, 179
Final Act. 6-7. Thus, the Examiner's use of these references fails to remedy
the deficiencies discussed above regarding Flaherty. Accordingly, we do not
sustain the rejection of claim 34 and claims 35--41 depending therefrom as
unpatentable over Flaherty, Makower '542, and Deaton.
Independent claims 52 and 62 recite limitations substantially similar
to those discussed above regarding claim 34. See Appeal Br. 20-21, 23
(Claims App.). Accordingly, for the reasons discussed above, we do not
sustain the rejection of claims 52, 62, and associated dependent claims
53---61 and 63-71, as unpatentable over Flaherty, Makower '542, and
Deaton.
Rejection (III)
The Examiner's use of Makower '280 does not remedy the deficiency
discussed above regarding Rejection (II). See Final Act. 12-13.
Accordingly, we do not sustain the rejection of claims 69-71 as unpatentable
over Flaherty, Makower '542, Deaton, and Makower '280.
DECISION
The Examiner's rejection of claims 34--41 and 52-71 is reversed.
REVERSED
7