Brian Kelly et al.

Patent Trials and Appeals Board

Jul 22, 2019

14114345 - (D) (P.T.A.B. Jul. 22, 2019)

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.
14/114,345 06/12/2014 Brian Kelly P0039602.USN7 6798
28390 7590 07/22/2019
MEDTRONIC VASCULAR, INC.
IP LEGAL DEPARTMENT
3576 UNOCAL PLACE
SANTA ROSA, CA 95403
EXAMINER
OUYANG, BO
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
07/22/2019 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):
rs.patents.five@medtronic.com
rs.vasciplegal@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte BRIAN KELLY, JOHN KELLY, GARY KELLY,
and BARRY MULLINS
____________________

Appeal 2018-006333
Application 14/114,345
Technology Center 3700
____________________

Before MICHAEL L. HOELTER, MICHELLE R. OSINSKI, and
LISA M. GUIJT, Administrative Patent Judges.

OSINSKI, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Brian Kelly et al. (“Appellants”)1 appeals under 35 U.S.C. § 134(a)
from the Examiner’s decision rejecting claims 1–6, 8–10, 34, 35, and 39–
46.2 We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 Appellants identify the real party in interest as “Medtronic Ardian
Luxembourg S.à.r.l., which is a subsidiary of Medtronic, Inc. [which in turn]
is a wholly-owned subsidiary of Medtronic plc.” Appeal Br. 1.
2 Claims 7, 11–33, and 36 are cancelled, and claims 37 and 38 are
withdrawn. Appeal Br. 19–20 (Claims App.).
Appeal 2018-006333
Application 14/114,345

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THE CLAIMED SUBJECT MATTER
Claims 1 and 6 are independent. Claim 1 is reproduced below.
1. A cryotherapeutic device, comprising:
an elongate shaft having a distal end portion, wherein the
shaft is configured to locate its distal end portion at a treatment
site within an anatomical lumen of a human patient;
a first balloon at the distal end portion of the shaft,
wherein the first balloon includes a flexible wall defining an
expandable interior volume;
a first supply lumen carried by the shaft;
a first exhaust lumen carried by the shaft, wherein the
first exhaust lumen is fluidly connected to the first supply
lumen via the interior volume of the first balloon;
a second balloon at the distal end portion of the shaft,
wherein the second balloon includes a flexible wall defining an
expandable interior volume fluidly separate from the first
supply lumen and from the first exhaust lumen, and wherein the
second balloon is configured to prevent the first balloon from
contacting a full circumference of a wall of the anatomical
lumen in any plane perpendicular to a length of the anatomical
lumen;
a second supply lumen carried by the shaft; and
a second exhaust lumen carried by the shaft, wherein the
second exhaust lumen is fluidly connected to the second supply
lumen via the interior volume of the second balloon, and
wherein the respective interior volumes of the first and second
balloons are non-overlapping.

EVIDENCE
The Examiner relied on the following evidence in rejecting the claims
on appeal:
Hon
Pageard
Ingle
Rizq

US 2009/0234345 A1
US 2011/0184400 A1
US 2011/0190751 A1
US 2011/0270238 A1

Sept. 17, 2009
July 28, 2011
Aug. 4, 2011
Nov. 3, 2011

Appeal 2018-006333
Application 14/114,345

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THE REJECTIONS
I. Claims 1, 2, 5, 9, 34, 35, and 39–42 stand rejected under 35 U.S.C.
§ 103 as unpatentable over Ingle and Pageard. Final Act. 2–7.
II. Claim 3 stands rejected under 35 U.S.C. § 103 as unpatentable
over Ingle, Pageard, and Rizq. Id. at 7–8.
III. Claim 4 stands rejected under 35 U.S.C. § 103 as unpatentable
over Ingle, Pageard, and Hon. Id. at 8–9.
IV. Claims 6, 8, 10, and 43–46 stand rejected under 35 U.S.C. § 103 as
unpatentable over Ingle and Hon. Id. at 9–12.

OPINION
Rejection I
The Examiner finds that Ingle teaches many of the limitations of
independent claim 1, including, in relevant part, “respective interior volumes
of the first and second balloons [that] are non-overlapping.” Final Act. 3. In
particular, the Examiner takes the position that because “the fluids stored in
their respective balloons do not intermingle, the volumes of the first and
second balloons do not overlap.” Id. The Examiner explains that the fluids
in the respective balloons do not and cannot intermingle because the first
balloon is supplied with a refrigerant and the second balloon is supplied with
a heat-transfer fluid, and these volumes must be separate from each other to
avoid leaking from one volume to another, which would prevent the device
from properly functioning. Id. at 13; Ans. 3.
Appellants respond that “[c]laim 1, by its plain meaning and by its
meaning in view of the [S]pecification and drawings, should not be
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Application 14/114,345

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interpreted as encompassing nested balloons, such as the nested inner and
outer balloons 104, 106 of Ingle.” Appeal Br. 10. Appellants explain that:
the interior volume of a balloon encompasses everything within
the wall of the balloon. For example, if a marble is inserted
into an inflated balloon, the marble is within the interior volume
of the balloon, even though the marble also has a volume. The
nested balloons of Ingle are no different. When one balloon is
inside another balloon in a nested arrangement, the respective
interior volumes of the balloons cannot reasonably be
interpreted to be non-overlapping. . . . [T]he Examiner’s
interpretation is contrary to the plain meaning of claim 1.
Id. at 11 (emphasis omitted).
Merely because the fluid inside interior 119 of inner balloon 104 is,
and must be kept, separate from the fluid inside space 118 between inner
balloon 104 and outer balloon 106 in order for Ingle’s device to function
does not support that “the respective interior volumes of the first and second
balloons are non-overlapping,” as claimed. Inner balloon 104 (like the
marble used in Appellants’ analogy) is still within the interior volume of
outer balloon 106. That is, the entirety of interior volume 119 of inner
balloon 104 is coincident with a portion of the interior volume of outer
balloon 106 (i.e., with that portion of the interior volume other than space
118 between inner balloon 104 and outer balloon 106). The Examiner erred
in considering the separation of interior volume 119 of inner balloon 104
from only a first portion (i.e., space 118) of the interior volume of outer
balloon 106 as sufficient to support that the interior volumes of inner and
outer balloons 104, 106 were non-overlapping. That is, the Examiner
disregarded that second portion of the interior volume of outer balloon 106
(i.e., the portion of the interior volume of outer balloon 106 in which inner
balloon 104 is disposed). When properly considering that second portion of
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Application 14/114,345

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the interior volume of outer balloon 106 in which inner balloon 104 is
disposed, it is clear that the entirety of the interior volume of inner balloon
104 occupies that second portion of the interior volume of outer balloon 106
(i.e., the portion other than space 118).
In the Answer, the Examiner adds that the Specification does not use
the term “non-overlapping” so as to provide any type of special definition
for the term and, thus, it would retain its ordinary and customary meaning.
Ans. 3–4. The Examiner finds an ordinary and customary meaning of “non-
overlapping” to be “‘not overlapping: such as not occupying the same area
in part.’” Id. at 4 (citing Merriam-Webster Online Dictionary).3 With this
meaning in mind, the Examiner states that “balloons with interior volumes

3 We agree with the Examiner that the Specification does not use the term
“non-overlapping.” Another ordinary and customary meaning of “overlap”
is “to extend over or past and cover a part of” (MERRIAM-WEBSTER,
https://www.merriam-webster.com/dictionary/overlap (last visited July 10,
2019) (“Merriam-Webster Online Dictionary”)), resulting in “non-
overlapping” also meaning “not extending over or past and covering a part
of.” When considering this interpretation of “non-overlapping,” it is not
readily apparent how Appellants’ Specification provides written description
support for, and enables one of skill in the art to make and use, a claimed
device that includes “respective interior volumes of the first and second
balloons [that] are non-overlapping.” Rather, Appellants’ Specification
describes, and the Figures illustrate, an interior volume of cryoballoon 234
extending over or past an interior volume of constraining element 236 and
covering it such that constraining element 236 expands into contact with
cryoballoon 234 to block a portion of cryoballoon 234 from coming into
contact with a portion of the vessel wall in which the balloons are disposed.
Spec. ¶ 43; Fig. 2. In other words, at least a portion of the respective interior
volumes of balloons 234, 236 must be in linear alignment relative to the
longitudinal axis of a vessel (i.e., the interior volume of constraining element
236 must extend over and cover at least a part of the interior volume of
cryoballoon 234) so as to provide the radial blocking function described and
illustrated in Appellants’ Specification. Id.
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that do not overlap would mean that the interior volumes are kept separate
from each other.” Id. at 3.
Appellants respond that:
[t]he Examiner’s position appears to be that the interior volume
119 of the inner balloon 104 is the entire space within the wall
of the inner balloon 104, whereas the interior volume 118 of the
outer balloon 106 is only the space between the wall of the
inner balloon 104 and the wall of the outer balloon 106.
Applicant respectfully submits, however, that the ordinary and
customary meaning of the interior volume of a balloon is the
entire space within the wall of the balloon. Therefore, the
Examiner’s interpretation, as it applies to the interior volume
118 of the outer balloon 106 of Ingle, is incorrect.
Reply Br. 2 (emphasis omitted).
The interior volume of Ingle’s inner balloon 104 occupies the same
area in part of the interior volume of Ingle’s outer balloon 106, contrary to
the plain and ordinary meaning of “non-overlapping” advanced by the
Examiner. More particularly, inner balloon 104 occupies that portion of the
interior volume of Ingle’s outer balloon 106 that is not identified as space
118 between inner balloon 104 and outer balloon 106. Thus, the Examiner
erred in determining that Ingle teaches “interior volumes of the first and
second balloons [that] are non-overlapping,” as claimed. The Examiner
does not explain how Pageard would remedy the deficiency of Ingle.
For the foregoing reasons (employing the Examiner’s definition of
“non-overlapping”), Appellants apprise us of error in the Examiner’s
rejection of claim 1 as unpatentable over Ingle and Pageard. Accordingly,
we do not sustain the Examiner’s rejection of claim 1, and claims 2, 5, 9, 34,
35, and 39–42 depending therefom, under 35 U.S.C. § 103(a) as
unpatentable over Ingle and Pageard.
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Application 14/114,345

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Rejections II–IV
The Examiner’s rejections of claims 3, 4, 6, 8, 10, and 43–46 rely on
the same deficient finding that Ingle teaches interior volumes of first and
second balloons that are non-overlapping. Final Act. 7–12. The Examiner
does not explain how Rizq and/or Hon would remedy the deficiency of the
combination of Ingle and Pageard. Id. Accordingly, we do not sustain,
under 35 U.S.C. § 103(a), the rejections of: claim 3 as unpatentable over
Ingle, Pageard, and Rizq; claim 4 as unpatentable over Ingle, Pageard, and
Hon; and claims 6, 8, 10, and 43–46 as unpatentable over Ingle and Hon.

DECISION
The Examiner’s decision to reject claims 1, 2, 5, 9, 34, 35, and 39–42
under 35 U.S.C. § 103(a) as unpatentable over Ingle and Pageard is reversed.
The Examiner’s decision to reject claim 3 under 35 U.S.C. § 103(a) as
unpatentable over Ingle, Pageard, and Rizq is reversed.
The Examiner’s decision to reject claim 4 under 35 U.S.C. § 103(a) as
unpatentable over Ingle, Pageard, and Hon is reversed.
The Examiner’s decision to reject claims 6, 8, 10, and 43–46 under
35 U.S.C. § 103(a) as unpatentable over Ingle and Hon is reversed.

REVERSED