Ex Parte Pai et al

Board of Patent Appeals and Interferences

Jan 11, 2012

10982385 (B.P.A.I. Jan. 11, 2012)

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.
10/982,385 11/05/2004 Suresh S. Pai ACI-013 8932
23410 7590 01/11/2012
Vista IP Law Group LLP
2040 MAIN STREET, Suite 710
IRVINE, CA 92614
EXAMINER
SEVERSON, RYAN J
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
01/11/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte SURESH S. PAI,
CELSO J. BAGAOISAN, and FARHAD KHOSRAVI
__________

Appeal 2010-008125
Application 10/982,385
Technology Center 3700
__________

Before DEMETRA J. MILLS, ERIC GRIMES, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to an apparatus for
sealing a puncture extending through living tissue. The Examiner entered
rejections for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
Appellants’ invention is directed to an apparatus for sealing puncture
wounds which can result from procedures that access a patient’s vasculature
percutaneously; “[f]or example, a hollow needle may be inserted through a
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Application 10/982,385

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patient’s skin and overlying tissue into a blood vessel. A guide wire may be
passed through the needle lumen into the blood vessel, whereupon the
needle may be removed” (Spec. [0002]). After needle removal, an
“introducer sheath may then be advanced over the guide wire into the vessel,
e.g., in conjunction with or subsequent to one or more dilators” allowing
access to the vessel for the purpose of performing medical procedures (id.).
Claims 1, 3-28, 31-40, and 60-70 stand rejected and appealed (App.
Br. 2).
1
Claim 1 is representative and reads as follows:
1. An apparatus for sealing a puncture extending through
tissue, comprising:
a tubular member comprising a proximal end, a distal end sized
for insertion through the puncture, a lumen extending between the
proximal and distal ends, and a distal opening in communication with
the lumen;
a bioabsorbable plug disposed within the lumen and comprising
a lumen extending between proximal and distal ends thereof, the plug
comprising hydrogel;
a bioabsorbable anchor element disposed within the lumen
proximal to the plug;
a pusher member slidable within the lumen of the tubular
member for deploying the plug and anchor element through the lumen
and out the distal opening of the tubular member; and
an elongate positioning member, the positioning member
having an expandable element on a distal end thereof, the positioning
member sized for slidably passing through the lumen of the tubular
member and the lumen of the plug.

The following rejections are before us for review:
(1) Claims 1, 3-14, 21-28, 31-40, and 60-70, under 35 U.S.C. § 103(a)
as obvious over Cates,
2
Sawhney,
3
and Zhu
4
(Ans. 3-5); and

1
Appeal Brief entered November 3, 2009.
2
U.S. Patent No. 6,162,240 (issued December 19, 2000).
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Application 10/982,385

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(2) Claims 15-20, under 35 U.S.C. § 103(a) as being obvious over
Cates, Sawhney, Zhu, and Vidal
5
(Ans. 5-6).
DISCUSSION
The Examiner found that Cates described an apparatus substantially as
claimed, except that Cates’ device did not have a plug composed of
hydrogel, and also did not have a bioabsorbable anchor proximal to its plug,
as recited in independent claims 1, 28, and 60 (Ans. 3-4). The Examiner
concluded, however, that modifying Cates’ device to include those features
would have been prima facie obvious, in view of the teachings of Sawhney
and Zhu that such features were known to be useful on devices of the type
described by Cates (id.).
“In proceedings before the Patent and Trademark Office, the
Examiner bears the burden of establishing a prima facie case of obviousness
based upon the prior art.” In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir.
1992).
In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007), while the
Supreme Court emphasized “an expansive and flexible approach” to the
obviousness question, it also reaffirmed the importance of determining
“whether there was an apparent reason to combine the known elements in
the fashion claimed by the patent at issue.” Id. at 418 (emphasis added).
Thus, “[o]bviousness requires more than a mere showing that the prior
art includes separate references covering each separate limitation in a claim

3
U.S. Patent No. 6,605,294 B2 (issued August 12, 2003).
4
U.S. Patent App. Pub. No. 2002/0072767 A1 (published June 13, 2002).
5
U.S. Patent No. 5,334,216 (issued August 2, 1994).
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Application 10/982,385

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under examination.” Unigene Laboratories, Inc. v. Apotex, Inc., 655 F.3d
1352, 1360 (Fed. Cir. 2011).
We agree with Appellants that the Examiner has not shown that the
cited references would have rendered the claimed apparatus prima facie
obvious to an ordinary artisan. In particular, we agree with Appellants that
the Examiner has not adequately explained why the cited references would
have suggested including Zhu’s bioabsorbable anchor in Cates’ device,
proximal to Cates’ bioabsorbable plug, as the claims require.
Specifically, claim 1 recites a tissue puncture-sealing apparatus that
has a bioabsorbable plug disposed in the lumen of a tubular member, and
also has “a bioabsorbable anchor element disposed within the lumen
proximal to the plug” (App. Br. 18 (claim 1)). The other independent claims
recite similar devices that also have this feature (id. at 23 (claim 28) and 25
(claim 60)).
Zhu describes a tissue puncture-sealing apparatus that includes a
relatively thin sponge 80 that contains a hemostatic agent and/or adhesive,
the sponge being deployed directly on the outer surface of the punctured
vessel while the tissue surrounding the vessel is retracted (Zhu [0055]-
[0059]); see also Figure 6). Once the sponge is in place on the vessel
surface, the retractors and sponge-applying device are removed, and the
“surrounding body tissues 96 collapse around the sponge 80 and push
member 84. The push member 84 [which is ultimately also removed] holds
the sponge 80 in position while body tissue 96 surrounds the sponge 80 and
while the adhesive cures” (id. at [0059]).
As the Examiner points out, in one embodiment Zhu’s device includes
a “lock apparatus 130 [which] is employed to help hold the sponge 80 in
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place against the artery wall 98” (id. at [0076]; see also Figures 17 and 18).
Thus, “the lock apparatus 130 holds the sponge 80 tightly in place adjacent
the wound w as shown in FIG. 18” (id.).
In contrast to Zhu’s sponge and lock apparatus, which adhere closely
to the punctured blood vessel and are surrounded by the overlying tissue,
Cates’ device uses a relatively long collagen plug 12 that extends essentially
from the surface of the skin to the wall of the punctured vessel, through the
intervening punctured tissue, which Cates calls the “access passage AP”
(see, e.g., Cates, col. 10, l. 3; see also Figure 9).
As Cates explains, once the plug 12 is deployed in the access passage,
“[a]s soon as the body fluids contact the plug 12, it starts to soften and any
seepage of blood through the blood vessel puncture BVP serves to start the
formation of a coagulum at the exterior end of the puncture BVP” (id. at col.
10, ll. 3-7). Ultimately, “[a]fter the physician checks to see if the seal has
been affected, the projecting end of the control member 20 can be pulled out
through the collagen plug 12 to complete the procedure and leave the
collagen plug 12 in place forming the coagulum CAM as seen in FIG. 9” (id.
at col. 10, ll. 17-22).
Thus, in contrast to Zhu’s vessel-adhering anchor feature, Cates’ plug
is configured to extend through the tissue adjacent to the punctured vessel all
the way through the access passage AP. Given that the express purpose of
Zhu’s anchor is to ensure close adherence of the hemostatic sponge to the
vessel wall, we are not persuaded that an ordinary artisan would have
combined such an anchor with a device containing Cates’ plug, since Cates’
plug is specifically configured to extend far from the vessel wall. Moreover,
given that Cates’ plug itself effectively acts to anchor the vessel puncture-
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sealing coagulum CAM in place (see id. at Figure 9), we are further
persuaded that the Examiner has not advanced an adequate rationale
explaining why an ordinary artisan would have been prompted to deploy
Zhu’s anchor next to Cates’ plug.
We agree with the Examiner that a claim “may be obvious in view of
a combination of references, even if the features of one reference cannot be
substituted physically into the structure of the other reference.” Orthopedic
Equip. Co., Inc. v. United States, 702 F.2d 1005, 1013 (Fed. Cir. 1983).
Ultimately, however, “[i]n determining whether obviousness is
established by combining the teachings of the prior art, the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir.
1995) (internal quotations omitted).
Here, for the reasons discussed, we are not persuaded that the cited
references would have suggested an apparatus having the claimed
combination of features to an ordinary artisan. We therefore reverse the
Examiner’s obviousness rejection of claims 1, 3-14, 21-28, 31-40, and 60-70
over Cates, Sawhney, and Zhu.
The Examiner also rejected claims 15-20 as obvious over Cates,
Sawhney, Zhu, and Vidal (Ans. 5-6). The Examiner cited Vidal as evidence
that an ordinary artisan would have considered it obvious to include
bioabsorbable plugs, shaped as recited in these dependent claims, in a device
such as that described by Cates (id.).
However, as the Examiner has pointed to no teaching in Vidal that
remedies the deficiencies, discussed above, with respect to the anchor
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feature required in each of the independent claims, we reverse this rejection
as well.

SUMMARY
We reverse the Examiner’s rejection of claims 1, 3-14, 21-28, 31-40,
and 60-70 as obvious over Cates, Sawhney, and Zhu.
We also reverse the Examiner’s obviousness rejection of claims 15-20
over Cates, Sawhney, Zhu, and Vidal.

REVERSED

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