Ex Parte Holman et al

Patent Trial and Appeal Board

Apr 30, 2013

11023055 (P.T.A.B. Apr. 30, 2013)

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.
11/023,055 12/27/2004 Thomas J. Holman 1001.2210101 3026
11050 7590 05/01/2013
SEAGER, TUFTE & WICKHEM, LLC
1221 Nicollet Avenue
Suite 800
Minneapolis, MN 55403
EXAMINER
OU, JING RUI
ART UNIT PAPER NUMBER
3773
MAIL DATE DELIVERY MODE
05/01/2013 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte THOMAS J. HOLMAN, TRACEE E. J. EIDENSCHINK,
and JAN WEBER
__________

Appeal 2011-003166
Application 11/023,055
Technology Center 3700
__________

Before DONALD E. ADAMS, DEMETRA J.MILLS and
ULRIKE W. JENKS, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for anticipation. We have jurisdiction under 35 U.S.C. § 6(b). We
reverse.
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Application 11/023,055

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STATEMENT OF CASE
1. A closure device for closing a body opening, comprising:

a single-layer planar patch including a patch body, with a pre-
formed access opening sized to receive a medical device, the access
opening being closable upon removal of the inserted medical device;

wherein the patch body is formed of a bioresorbable material;
and
wherein the patch body includes a self sealing gel material,
wherein the self sealing gel material comprises a flowable
procoagulant.

Cited References

Zhu US 2002/0072767 A1 Jun. 13, 2002

Grounds of Rejection
Claims 1, 4, and 6 are rejected under 35 U.S.C. § 102(b) as being
anticipated by Zhu (US Pub. No.: 2002/0072767).

FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages 3-
4.

Discussion
ISSUE
The Examiner concludes that
Zhu discloses a closure device, comprising: a single-layer
planar patch (120, the sponge 120 is a single-layer planar patch
when the hemostatic layer 122 and the elastic layer 124 is
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Application 11/023,055

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integrally formed, Para .[0072]) having a patch body (122) with
a pre-formed access opening (150); and wherein the patch body
formed of a bioresorbable material (collagen is bioresorbable,
Para. [0062]) is self sealing to close the access opening upon
removal of the inserted medical device (Para.[0073]); the patch
body also includes a self sealing gel material (highly elastic
layer 124 formed of material such as polyurethane, SDS, or
silicon rubber, Para. [0073]), the self sealing gel comprises a
flowable procoagulant (Para. [0062], liquid clotting agent or
Paras.[0066]-[0072], the flowable fibrin tissue sealant is a
flowable procoagulant) and a clot forming material hemostatic
sponge layer 122 has material such as hemostatic agent,
Para.[0072]).

(Ans. 3- 4.)
Appellants argue that Zhu does not disclose an embodiment that
includes all the features of claim 1. These are features that are found in
separate and distinct embodiments of Zhu. (Reply Br. 3.)
Appellants further argue that
The text cited by the Examiner in the Advisory Action
teaches the presence of two layers in body 120. The presence or
absence of a layer of cement 126, or the method of forming the
body, does not alter the disclosed presence of layers 122 and
124. The subsequent disclosure of paragraph 73 indicates that
the orientation of the layers during use is important to the
functioning of the device and that the layers have different
properties and functions within the body, e.g., hemostasis and
elastic contraction. As discussed in the communication of
December 29, 2009, the ordinary meaning of layer encompasses
a level of material different from the material above or below it
and it appears to be used in that sense by Zhu. Materials suited
for use as the elastic layer (polyurethane, SDS, and silicon (sic)
rubber; paragraph 72) are different from hemostatic sponge
materials. Moreover, such materials are not gel materials.

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4
Further, as will be seen from the sequence depicted in
Figs. 14-16, body 120 of Zhu does not include “a pre-formed
access opening sized to receive a medical device” in the initial
Fig. 14. The opening 82 is characterized as puncture hole
through which catheter 32 extends in Fig. 15 and which is
closed, at least in part, by highly elastic layer 124 in Fig. 16.

The access opening 150 referred to in the Final Office
Action is found only in the embodiment of Figs. 19-21 and the
description at paragraph [0079] which characterizes that patch
as "In a further additional embodiment illustrated in FIGS. 19-
21, a multi-layer patch 140 is used". (Emphasis added.) Body
120 of Zhu is disclosed to include a hemostatic layer 122 which
comprises a hemostatic agent as described with respect to
sponge 80 at paragraph 62. In that paragraph, two hemostatic
agent options are disclosed. In some embodiments, the sponge
itself may be made of a hemostatic agent. In other
embodiments, a sponge may be impregnated with a thrombin,
"a liquid clotting agent". (Emphasis added.) Accordingly, the
hemostatic layer 122 comprises two components, neither of
which is a gel "wherein the self sealing gel material comprises a
flowable procoagulant" as recited in claim 1. The Examiner
appears to have incorrectly read claim 1 to recite that the self
sealing gel may be replaced by a procoagulant, rather than that
the gel comprises a flowable procoagulant added to the gel,
thereby ignoring the claim's plain language and the teaching of
the specification at page 18, lines 18-21 which must be used to
interpret the claim as it would be understood by one of ordinary
skill in the art: "a procoagulant, such as a flowable mixture of
thrombin, collagen and diluent can be added to a gel to provide
a puncturable media seal or closure" (Emphasis added.)

(App. Br. 6-7.)

The issue is: Does the cited prior art teach each element as arranged
in the claim?

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PRINCIPLES OF LAW
In order for a prior art reference to serve as an anticipatory reference,
it must disclose every limitation of the claimed invention, either explicitly or
inherently. See In re Schreiber, 128 F.3d 1473, 1477(Fed. Cir. 1997). To
anticipate, every element and limitation of the claimed invention must be
found in a single prior art reference, arranged as in the claim. Karsten Mfg.
Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir. 2001).

ANALYSIS
We do not find that the Examiner has established a prima facie case of
anticipation on the evidence before us. To anticipate, every element and
limitation of the claimed invention must be found in a single prior art
reference, arranged as in the claim. Karsten Mfg. Corp. v. Cleveland Golf
Co., 242 F.3d 1376, 1383 (Fed. Cir. 2001). The Examiner argues in the
“Response to Arguments” section of the Answer that, “Zhu discloses
"various features and aspects of the disclosed embodiments can be combined
with or substituted for one another in order to form varying modes of
disclosed modular arrangement and method.” (Ans. 4.) This language is the
language of obviousness, not anticipation. The Examiner has not provided
evidence of every element and limitation of the claimed invention in the
single prior art reference, arranged as in the claim. In particular, the
Examiner directs attention to two different embodiments of Zhu’s invention
to reach the requirements of Appellants’ claimed invention (see Ans. 3-4,
citing Zhu 4: ¶ [0062] and 5: ¶ [0072]). The Examiner does not identify an
evidentiary basis in Zhu of a single embodiment that comprises all the
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elements required by Appellants’ claimed invention. We have no alternative
obviousness rejection before us.
The anticipation rejection is reversed.

CONCLUSION OF LAW
The cited references do not support the Examiner’s anticipation
rejection. The anticipation rejection is reversed.

REVERSED

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