THE FLORIDA INTERNATIONAL UNIVERSITY BOARD OF TRUSTEES

Patent Trials and Appeals Board

Sep 17, 2020

2020001105 (P.T.A.B. Sep. 17, 2020)

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.
14/601,451 01/21/2015 Thomas Edward Claiborne III 29171/43743B 2512
4743 7590 09/17/2020
MARSHALL, GERSTEIN & BORUN LLP
233 SOUTH WACKER DRIVE
6300 WILLIS TOWER
CHICAGO, IL 60606-6357
EXAMINER
HERBERMANN, ERICH G.
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
09/17/2020 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):
mgbdocket@marshallip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte THOMAS EDWARD CLAIBORNE, III
RICHARD T. SCHOEPHOERSTER, and
SIOBHAIN LYNN GALLOCHER
Appeal 2020-001105
Application 14/601,451
Technology Center 3700
Before JENNIFER D. BAHR, CHARLES N. GREENHUT, and
MICHAEL J. FITZPATRICK, Administrative Patent Judges.
BAHR, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant appeals from the
Examiner’s decision to reject claims 11, 12, 14, 15, 18–20, 22–24, and 28–
32.1 We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42(a). Appellant identifies “The Florida International
University Board of Trustees” as the real party in interest. Appeal Br. 2.
Appeal 2020-001105
Application 14/601,451

2
CLAIMED SUBJECT MATTER
Appellant’s invention is directed to “a catheter deliverable artificial
heart valve and delivery system therefor.” Spec. ¶ 2. Claim 11, reproduced
below, is illustrative of the claimed subject matter:
11. A system for intravascular delivery of a heart valve
prosthesis, the system comprising:
a handle;
a flexible elongated sheath having a first end and a
second end, the first end connected to and extending from the
handle and the second end disposed opposite the handle;
a cavity at least partially defined by the second end of the
elongated sheath, the cavity adapted to contain a heart valve
prosthesis during intravascular delivery of the heart valve
prosthesis;
a tapered tip coupled to the second end of the elongated
sheath adjacent to the cavity, the tapered tip adapted to guide
the elongated sheath during intravascular delivery of the heart
valve prosthesis, the tapered tip and the elongated sheath being
separable such that the heart valve prosthesis can be released
from the cavity in the elongated sheath upon proper positioning
of the heart valve prosthesis;
a stop plug disposed in the elongated sheath and adjacent
the cavity;
a string fixed to an inside surface of the elongated sheath
at a location between the stop plug and the handle and
extending through the sheath to the handle such that a user can
pull the string to bend the elongated sheath to facilitate
navigation of the elongated sheath during intravascular delivery
of the heart valve prosthesis.

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Application 14/601,451

3
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Hammerslag US 5,372,587 Dec. 13, 1994
Thompson US 2002/0120322 A1 Aug. 29, 2002
Sakakine US 2007 /0260225 A1 Nov. 8, 2007

REJECTIONS
Claims 11, 12, 14, 15, 18–20, 24, and 29–32 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Thompson and Sakakine.
Claims 11, 18, 22, 23, and 28 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Thompson and Hammerslag.
OPINION
Appellant makes essentially the same arguments against both
rejections. Appeal Br. 9–11. Further, Appellant relies solely on the
arguments presented against the rejections of independent claim 11 in
contesting the rejections of independent claim 18. Appeal Br. 11–12.
Appellant does not present any separate arguments for the dependent claims,
aside from their dependence from either claim 11 or claim 18. Id.
Accordingly, we decide the appeal of both rejections on the basis of claim
11, and the remaining claims stand or fall with claim 11.
The Examiner finds that Thompson discloses a system substantially as
recited in claim 11, but that
Thompson fails to directly disclose: a string fixed to an inside
surface of the elongated sheath at a location between the stop
plug and the handle and extending through the sheath to the
handle such that a user can pull the string to bend the elongated
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Application 14/601,451

4
sheath to facilitate navigation of the elongated sheath during
intravascular delivery of the heart valve prosthesis.
Final Act. 2–3, 10–11. The Examiner finds, however, that Sakakine teaches
a string (tensioning device 86) fixed to an inside surface of a sheath of a
medical device at a location between the stop plug and the handle and
extending through the sheath to the handle such that a user can pull the
string to bend the sheath to facilitate navigation of the sheath during
intravascular delivery of a heart valve prosthesis. Id. at 3 (citing Sakakine,
Fig. 4; ¶ 37).
The Examiner determines it would have been obvious to modify the
outer tube (outer tubular member 16) of Thompson to be bendable and to
provide internal pull wires as taught by Sakakine to facilitate steering the
device through vasculature. Final Act. 4 (citing Sakakine ¶ 37). According
to the Examiner, once the modification is made, at least a portion of the
length of the wire, which would be passed through Thompson’s tubular
member 16, would be located between the stop plug and the handle because
tubular member 16 “passes over the stop plug and the handle in order to
manipulate the prosthesis through the vasculature.” Id.
In the alternative, the Examiner finds that Hammerslag teaches a
string (pull ribbon 234) fixed to an inside surface of a sheath at a location
between the stop plug and the handle and extending through the sheath to the
handle such that a user can pull the string to bend the sheath to facilitate
navigation of the sheath during intravascular delivery of a heart valve
prosthesis. Final Act. 11. The Examiner determines it would have been
obvious to modify Thompson’s device to be bendable and provide internal
pull wires as taught by Hammerslag to facilitate steering the device through
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Application 14/601,451

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vasculature. Id. at 12 (citing Hammerslag 3:17–25; 29:1–12). According to
the Examiner, once the modification is made, the wire will be located
throughout the length of the device because “the pull wires terminate at the
distal tip” as seen in Figure 24 so the user can pull the wires when needed.
Id. Thus, according to the Examiner, “a portion of the wire will be at a
location between the stop plug and the handle since the wire runs the length
of the tube 16 which in turn covers the plug.” Id.
Appellant does not specifically dispute any of the Examiner’s findings
or reasoning. Rather, Appellant contends that “each of the proposed
combinations of Thompson and Sakakine and Thompson and Hammerslag
would render the stent delivery device of Thompson inoperable for its
intended purpose.” Appeal Br. 10. More specifically, Appellant argues that
modifying Thompson to include Sakakine’s tensioning device 86 or
Hammerslag’s pull ribbon 234 would render Thompson’s stent delivery
device
inoperable for its intended purpose by affecting the ability of
the interlocking structures 82 and 84 to remain locked when a
tensioning device or string (1) pulls the outer tubular member
16 relative to the inner tubular member 14 and fully retracts the
outer tubular member 16 before reaching the deployment site,
or (2) applies a bending moment to the device 10 and causes the
interlocking structures 82 and 84 to move out [of] interlocking
engagement.
Id.
The Examiner responds by explaining that, in the modified device of
Thompson, either in view of Sakakine or in view of Hammerslag, the pull
wire, which would be in outer tubular member 16, would not interact with
the interlocked portions at all and would not interfere with their ability to
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Application 14/601,451

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lock in place. Ans. 3, 4. The Examiner also points out that “there is no
indication in the disclosure of Thompson that supports the notion that the
interlocked portions would not work properly if the device were bent.” Id. at
4. The Examiner reasons that one of ordinary skill in the art would know
how to incorporate into Thompson a tensioning device as taught by Sakakine
or a pull ribbon as taught by Hammerslag for steering to ensure “the device
can bend and operate as intended.” Id. at 3–4.
Based on the record before us, the Examiner has the better position.
“A person of ordinary skill is also a person of ordinary creativity, not an
automaton.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421(2007). Such a
person would readily appreciate the advantages of providing a means to
deflect the distal end of Thompson’s implant delivery system to navigate
through tortuous conduits or cavities within the body as taught by Sakakine
and to be steerable through body lumens or cavities as taught by
Hammerslag. See Sakakine ¶¶ 37–39; Hammerslag 1:14–20, 29:3–13.
Further, such a person would know how to design Thompson’s interlocking
structures 82, 84 to be sufficiently robust that they will remain interlocked
even when the distal end of the delivery system is subjected to a degree of
deflection necessary to steer the system to facilitate navigation through
vasculature and would know how to design outer tubular member 16 and
inner tubular member 14 to limit deflection to a degree that will not damage
stent 12. Appellant does not provide any evidence or persuasive technical
reasoning to show that incorporating a steering means including a pull string
in Thompson’s device in a manner to create an operable device would have
been beyond the technical grasp of a person having ordinary skill in the art.
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The Examiner also explains why applying tension on the tensioning
device or pull ribbon would not cause Thompson’s outer tubular member 16
to retract prematurely as Appellant contends. Ans. 4–5. Appellant does not
dispute the Examiner’s findings or technical analysis on this issue.
For the above reasons, Appellant fails to apprise us of error in the
Examiner’s conclusion that the subject matter of claim 11 would have been
obvious, based on either a combination of Thompson and Sakakine or a
combination of Thompson and Hammerslag. Accordingly, we sustain the
rejection of claim 11, as well as claims 12, 14, 15, 18–20, 24, and 29–32,
which fall with claim 11, as unpatentable over Thompson and Sakakine. We
also sustain the rejection of claim 11, as well as claims 18, 22, 23, and 28,
which fall with claim 11, as unpatentable over Thompson and Hammerslag.
CONCLUSION
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
11, 12, 14,
15, 18–20,
24, 29–32
103(a) Thompson,
Sakakine
11, 12, 14,
15, 18–20,
24, 29–32

11, 18, 22,
23, 28
103(a) Thompson,
Hammerslag
11, 18, 22,
23, 28

Overall
Outcome
11, 12, 14,
15, 18–20,
22–24, 28–32

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Application 14/601,451

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TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED