Ex Parte Blom

Patent Trial and Appeal Board

Jun 15, 2017

13318581 (P.T.A.B. Jun. 15, 2017)

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.
13/318,581 11/02/2011 Eric D. Blom 1069-219481 7057
23643 7590 06/19/2017
Barnes & Thornburg LLP (IN)
11 S. Meridian Street
Indianapolis, IN 46204
EXAMINER
TANNER, JOCELIN C
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
06/19/2017 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):
INDocket@btlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ERIC D. BLOM1
Appeal 2016-001437
Application 13/318,581
Technology Center 3700
Before: JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims directed
to a fistula sealing device. The Examiner rejects the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 According to Appellant, Hansa Medical Products, Inc., is the real party in
interest. Appeal Br. 2.
Appeal 2016-001437
Application 13/318,581
STATEMENT OF THE CASE
Claims 4—7, 10—15, 17, and 27—31 are on appeal, and can be found in
the Claims Appendix of the Appeal Brief. Claim 4 is representative of the
claims on appeal, and reads as follows:
4. An adjustable device for sealing a fistula including a first
flange for orienting against a first wall of the fistula, a second
flange for orienting against a second wall of the fistula, and at
least one stem coupling the first and second flanges, the at least
one stem passing through a respective at least one opening
provided in at least one of the first and second flanges to permit
adjustment of the location of said at least one of the first and
second flanges along the length of the at least one stem, the at
least one stem exhibiting an elongation of greater than about
.65 mm/N of force applied between the first and second flanges
in the range of elongation between about 0 mm to about 15 mm
and a tissue graft material to promote healing of the fistula.
Appellant seeks review of the following rejections:
I. claims 4—6, 10—13, 15, 17, and 27—31 under 35 U.S.C. § 103(a) as
unpatentable over Bennett,2 Hoffman,3 and Shu;4
II. claim 16 under 35 U.S.C. § 103(a) as unpatentable over Bennett,
Hoffman, Shu and further in view of Moenning;5 and
III. claim 18 under 35 U.S.C. § 103(a) as unpatentable over Bennett,
Hoffman, Shu and further in view of Laston.6
Since all of these rejections rely upon the teaching of Bennett, Hoffman,
2 Bennett, US 2010/0042144 Al, published Feb. 18, 2010.
3 Hoffman et al., US 2008/0071310 Al, published Mar. 20, 2008
(“Hoffman”).
4 Shu, US 6,508,784 Bl, issued Jan. 21, 2003.
5 Moenning et al., US 5,941,898, issued Aug. 24, 1999 (“Moenning”).
6 Laston et al., US 5,861,003, issued Jan. 19, 1999 (“Laston”).
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Appeal 2016-001437
Application 13/318,581
and Shu regarding the elongation of the stem, the same issue is dispositive
for all of these rejections, so we will consider the rejections together.
Findings of Fact
FF1. Bennet teaches a medical device for repairing perforations and tissue
wall defects. Bennet, Abstract. Figure 2D, reproduced below, shows
such a device.
Figure 2D, reproduced above, an elongate body 4 containing barbs.
Bennet 134. The device contains a foam structure 6, “[t]he proximal
portion 6b of the foam structure 6, which may be generally flat, is
positioned adjacent a tissue wall 30.” Bennet 136. The device also
has an outer member 10, and an inner member 8. Bennet 136.
FF2. Bennet teaches that the elongate member 4 contains barbs that are
“formed integrally with the elongate body 4 ... . The barbs can be
arranged in any suitable pattern, for example helical, linear, or
randomly spaced. . . . The barbs can be arranged in various directions
at various angles. In some embodiments, the wound closure device
may include a staggered arrangement of large or small barbs.” Bennet
134.
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Appeal 2016-001437
Application 13/318,581
FF3. Bennett teaches that the device may be made of biodegradable and
non-biodegradable materials. See Bennet H 34 and 47. “Suitable
non-biodegradable materials [that] may be used to construct the
wound closure device” includes silicone among others. Bennet 147.
FF4. Hoffman also teaches a device for sealing punctures of openings.
Hoffman, Abstract. Figure 12, reproduced below, shows an
exemplary device.
The device includes a rod 100, a first obstructing body 120, and a
second obstructing body 130. Hoffman 1 80. “[T]he rod may include
structural elements 160, such as a ‘tie wrap’-like elements for
adjusting the distance between obstructing bodies 120 and 130.”
Hoffman 191. “A ‘rod’ refers to a center portion of a structural
member and it may include a rod, tube, a string, a thread, or a series of
wires.” Hoffman 173. In addition the rod may also contain a sealing
material 150 wrapped around the rod. See Hoffman 191.
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Appeal 2016-001437
Application 13/318,581
FF5. Hoffman teaches that the rod can have a length of 0.2 to 5 cm and a
diameter of 0.1 to 10 centimeters. See Hoffman | 82.
FF6. Hoffman teaches that “[t]he rod, and the first and second obstructing
bodies of the structural member of the present invention may be
formed as an integral unit.” Hoffman | 53.
FF7. Hoffman teaches that “the sealing material [150] may include a
reconstituted or a naturally-derived collagenous material, such as
ECM material. The sealing material is provided for enhancement of
sealing at the puncture site by expanding at the puncture.” Hoffman |
94.
FF8. Shu teaches a balloon catheter with a tubular centering structure. Shu,
Abstract. Shu teaches that “[t]he tubular centering structure in its
preferred embodiment may have an outside diameter ranging from
about 2.0 to 4.0 millimeters with a wall thickness as thin as 0.01.”
Shu 8:37-39.
FF9. Shu teaches durometer measurements of their catheter shaft material.
This measures the hardness of a material. “The durometer of the
material forming the catheter shaft may preferably be in a range from
Shore 5A to Shore 100A. Shu 7:33—35. Shu teaches that a suitable
material for the catheter includes silicone. Shu 7:42. Shu teaches that
“[a] range of particular advantage occurs from a Shore hardness of
35D to 100D for strength and pushability.” Shu 7:35—38.
Principle of Law
“[0]bviousness requires a suggestion of all limitations in a claim.”
CFMT, Inc. v. Yieldup Inti Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003)
(citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).
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Appeal 2016-001437
Application 13/318,581
Analysis
Bennet teaches a device for closing perforations in tissue. The device
contains a flange an elongated body (a rod) and an inner and outer member.
See FF1. Bennett teaches that the device may be made of non-biodegradable
material such as silicone. FF3. The elongated body of Bennet also contains
barbs. FF2. Hoffman similarly teaches a puncture sealing device that also
contains two flanges (obstructing device 120 and 130) that are held together
by a rod. FF4. The rod contains a tie like structure that allows for
adjustment to be made between the two obstructing devices. FF4. The rod
can have a length of 0.2 to 5 cm. FF5. Hoffman’s rod encompasses
structures such as tube and string structures. FF4. In addition, Hoffman
teaches that the rod may also be wrapped with a sealing material. FF4 and
FF7. Shu teaches tubular structures that are made of silicone and that can
have a diameter of 2 to 4 mm. FF8 and FF9. Shu teaches that hardness
factor between 35D and 100D is particularly advantageous because this has
good strength for pushability. FF9.
The Examiner concludes that based on the combination of references
it would have been obvious to modify the rod structures to have a hardness
as suggested by Shu.
The durometer would provide strength and pushability for the
silicone shaft. Therefore, it would have been obvious to have
formed the silicone of the combination of Bennett and Hoffman
of 60 durometer, as taught by Shu, to provide strength and
pushability. With this modification, per instant specification
[0047] the stem of the device of Bennett, Hoffman and Shu
would be capable of exhibiting an elongation greater than about
.65mm/N of force applied between the first and second flanges
in the range of elongation between about 0 mm to about 15mm.
Ans. 3^4.
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Appeal 2016-001437
Application 13/318,581
Appellant contends that “the prior art references themselves, fails to
provide support for the Examiner’s assertion that the proposed combination
of Bennett, Hoffman, and Shu would necessarily be ‘capable of exhibiting
the claimed elongation.” Appeal Br. 8. Appellant directs us to Table II of
the Specification that shows materials having the same durometer measure [,
a measure of hardness,] do not necessarily have the same elongation
properties. See Appeal Br. 7; see also Spec. 10.
We find that Appellant has the better position. Here, the Examiner’s
rejection relies on inherency. Specifically the rejection relies on the
teaching of Shu that a particular hardens level in a product made of silicone
is desirable in order to achieve the requisite push ability for the catheter. See
FF9. “Inherency . . . may not be established by probabilities or possibilities.
The mere fact that a certain thing may result from a given set of
circumstances is not sufficient.” MEHL/Biophile Int'l. Corp. v. Milgraum,
192 F.3d 1362, 1365 (Fed. Cir. 1999). To the extent that it might have been
obvious to optimize elongation levels in the rod element is not a question
before us because the Examiner fails to provide any such discussion or
evidence. What we can say is that the Examiner’s articulated rationale is not
supported by a sufficient evidentiary basis to support a conclusion of
obviousness.
Accordingly, we re vers all rejections that rely on the combination of
Bennett, Hoffman, and Shu.
SUMMARY
We reverse all rejections on appeal.
REVERSED
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