Ex Parte Sturtevant

Patent Trial and Appeal Board

Jun 7, 2013

11891421 (P.T.A.B. Jun. 7, 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.
11/891,421 08/10/2007 Donald Lee Sturtevant 615.001US1 1716
97462 7590 06/10/2013
Mark A. Litman & Associates, P.A.
7001 Cahill Road, Ste. 15A
Edina, MN 55439
EXAMINER
TEMPLETON, CHRISTOPHER L
ART UNIT PAPER NUMBER
3773
MAIL DATE DELIVERY MODE
06/10/2013 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 DONALD LEE STURTEVANT
__________

Appeal 2012-000981
Application 11/891,421
Technology Center 3700
__________

Before TONI R. SCHEINER, FRANCISCO C. PRATS, and
ERICA A. FRANKLIN, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a method for
filling an internal volume in a patient created by a surgical procedure. The
Examiner entered rejections for anticipation and obviousness.
We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
“Healthy blood vessels are typically harvested to repair damaged
vessels in other more critical parts of a human circulatory system” (Spec. 3).
For example, “the saphenous vein is harvested from a patient‟s leg and
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Application 11/891,421

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utilized in bypass surgery where damaged and blocked arteries of the heart
region of the patient are bypassed with the healthy blood vessel harvested”
(id.).
Appellant‟s invention is directed to a method of inserting “flexible
tubing into surgical cavities left by vein harvesting and the release of
volumes of clotting agent in a manner that enables filling of the cavity with a
blood clot to prevent the retention of an open volume within a patient” (id. at
6).
Claims 11-19 stand rejected and appealed (see App. Br. 5). Claims 11
and 19, the independent claims, illustrate the appealed subject matter and
read as follows:
11. A method for filling an internal volume within a patient
created by a surgical procedure where there is blood available within
the volume comprising:
inserting a flexible tubing having a surface material and
a free-flowing blood clotting material enclosed within the surface
material of the tubing into the volume; and
removing the surface material to leave a volume of
free-flowing blood clotting material within the volume from which the
surface material has been removed.

19. A method for filling an internal volume within a patient
created by a surgical procedure where there is blood available within
the volume comprising:
inserting a flexible tubing having a surface material and a
fill consisting essentially of free-flowing blood clotting material
enclosed within the surface material of the tubing into the volume;
and
removing the surface material to leave a volume
consisting essentially of free-flowing blood clotting material in the
blood within the volume from which the surface material has been
removed.

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The following rejections are before us for review:
(1) Claims 11 and 19, under 35 U.S.C. § 102(b) as anticipated by
Ashby
1
(Ans. 4-5);
(2) Claims 11-18, under 35 U.S.C. § 103(a) as obvious over Clague,
2

Obermiller,
3
and Weldon
4
(Ans. 5-7);
(3) Claims 11-14, under 35 U.S.C. § 103(a) as obvious over
Obermiller and Weldon (Ans. 7-9); and
(4) Claims 11 and 15, under 35 U.S.C. § 103(a) as obvious over
Clague and Cragg
5
(Ans. 9-10).
ANTICIPATION – ASHBY
Appellant argues that Ashby does not anticipate claims 11 and 19
because the material deployed by Ashby “is a solid, sponge material that is
injected as a single mass (not free-flowing material)” (App. Br. 11).
The Examiner responds that “Ashby does disclose hemostasis by
a free flowing material- liquid thrombin in the sponge (column 4, lines 56-
58 discloses that hydrating means to fully saturate with fluid thrombin, and
column 5, line 6-column 6, line 65 discloses inserting the thrombin hydrated
sponge into a volume, which causes hemostasis)” (Ans. 10).
We find that Appellant has the better position.
It is well settled that, “[d]uring examination, „claims . . . are to be
given their broadest reasonable interpretation consistent with the
specification, and . . . claim language should be read in light of the

1
U.S. Patent No. 6,964,658 B2 (issued Nov. 15, 2005).
2
U.S. Patent App. Pub. No. 2008/0161843 A1 (filed Oct. 16, 2007).
3
U.S. Patent App. Pub. No. 2008/0004657 A1 (filed May 1, 2006).
4
U.S. Patent No. 5,419,765 (issued May 30, 1995).
5
U.S. Patent No. 6,610,026 B2 (issued Aug. 23, 2003).
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specification as it would be interpreted by one of ordinary skill in the art.‟”
In re American Academy Of Science Tech Center, 367 F.3d 1359, 1364 (Fed.
Cir. 2004) (quoting In re Bond, 910 F.2d 831, 833 (Fed.Cir.1990))).
Here, claims 11 and 19 both require the flexible tubing inserted into
the patient to contain “a free-flowing blood clotting material” (App. Br. 21,
22 (claims 11 and 19, respectively)).
We note, as the Examiner points out, that Ashby describes saturating a
sponge with liquid thrombin before inserting the thrombin-impregnated
sponge into a patient (see Ashby, col. 4, ll. 55-57). We acknowledge that a
liquid thrombin preparation, by itself, might reasonably be considered a free-
flowing blood clotting material.
However, once impregnated into the sponge, the sponge restricts the
flow of the liquid thrombin, such that the overall sponge-thrombin
composition is not a flowable material. We are therefore not persuaded that
the thrombin-impregnated sponge material Ashby inserts into its patients can
reasonably be considered a free-flowing blood clotting material, as required
by claims 11 and 19.
The Specification supports this interpretation by expressly
distinguishing between free-flowing blood clotting particles and material
deployed in a containment system:
The beads or particles may be free flowing or be
supported on or in a containment system. For example, the
particles may be loosely adhered with biocompatible binder that
may dissolve or will be absorbed or adsorbed by the porous
particles or porous beads and the patients[‟] natural biological
processes in the cavity with blood thereon.

(Spec. 12 (emphasis added).)
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Thus, as we are not persuaded that the Examiner‟s finding of
anticipation is based on a reasonable interpretation of claims 11 and 19,
particularly when viewed in light of the Specification, we reverse the
Examiner‟s rejection under § 102(b) of those claims over Ashby.
OBVIOUSNESS –
CLAGUE, OBERMILLER, AND WELDON
In rejecting claims 11-18 as obvious over Clague, Obermiller, and
Weldon, the Examiner cited Clague as teaching a process of using flexible
tubing to fill a surgically created volume, substantially as recited in claim
11, but conceded that Clague differed from the claim in that Clague did not
“expressly disclose the free flowing material enclosed within the tube” (Ans.
6). To address that deficiency, the Examiner cited Weldon as disclosing a
similar process “with free-flowing blood clotting material/particulate 65
enclosed within the tubing, in order to hasten clotting and assist in
preventing further bleeding from an aperture” (id. at 7 (citing Weldon, col.
7, ll. 1-6 and 37-46)).
The Examiner cited Obermiller as evidence that an ordinary artisan
would have considered it obvious to use guidewires to open the tube of
Clague‟s device as recited in a number of Appellant‟s claims depending
from claim 11 (id. at 6; see also App. Br. 21 (claim 12)).
Based on the references‟ teachings, the Examiner reasoned that an
ordinary artisan would have considered it obvious to include guidewires in
Clague‟s device, and also to include the clotting material described by
Weldon “to hasten clotting and assist in preventing further bleeding from the
internal volume . . . . Once modified, the free-flowing blood clotting
material would be left in the internal volume as a particulate material, from
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which the surface material had been removed once the guidewires are
pulled” (Ans. 7).
We reverse this rejection as well.
In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme
Court emphasized “an expansive and flexible approach” to the obviousness
analysis. Id. at 415. However, the Court 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.
Thus, even post-KSR, “[o]bviousness requires more than a mere
showing that the prior art includes separate references covering each
separate limitation in a claim under examination.” Unigene Laboratories,
Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir. 2011).
Instead, “[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).
In this instance, similar to Appellant, Clague is directed to treating the
void left after removing a blood vessel (see Clague [0045]). As Clague
explains, after coring out the tissue surrounding the harvested vessel, the
practitioner can introduce a hemostatic control means, for example, “a
thrombogenic substance such as fibrinogen, fibrin and/or thrombin placed in
the track left by the cutting device” (id.).
Clague discloses that, “[a]lternatively, or in combination with a
biological sealant, a biocompatible or biodegradable tube can be enclosed
within the cutting device to be delivered as the cutting device is advanced
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over the vessel or after the cutting device has completed coring out the
vessel and adjoining tissue” (id.). Clague explains that the tube “exerts
pressure on the cut branch vessels and can be either removed or, in the case
of a biodegradable tube, left to dissolve or degrade over a period of a few
days, for example” (id.).
Given that Clague‟s tube is deployed for the purpose of exerting
pressure on the interior of the space in the patient left behind after vessel
removal, and can remain in that space for several days, we are not persuaded
that the Examiner has adequately explained why an ordinary artisan would
have been prompted to include a free-flowing clotting material inside the
tube, and then remove the tube so as to cause clotting, as recited in claim 11.
Thus, even in view of Weldon‟s teaching of the suitability of using a
free-flowing clotting agent to aid in sealing blood vessel punctures used to
access a patient‟s vasculature for surgical procedures (see Weldon, col. 7, ll.
1-61), we are not persuaded that the cited references would have suggested
practicing the process recited in Appellant‟s claim 11. As we are not
persuaded that Obermiller‟s teachings regarding the use of a
guidewire-assisted tube in the closing of fistulas (see, e.g., Obermiller
[0164]) remedies the deficiency in the combination of Clague and Weldon,
we reverse the Examiner‟s rejection of claim 11, and its dependents, over
Clague, Obermiller, and Weldon.
OBVIOUSNESS – OBERMILLER AND WELDON
In rejecting claims 11-14 as obvious over Obermiller and Weldon, the
Examiner cited Obermiller as describing a method for filling an internal
volume in a patient, substantially as recited in claim 11 (Ans. 7-8). The
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Examiner again relied on Weldon for its teaching of deploying free-flowing
blood clotting material when sealing a blood vessel puncture (see id. at 8).
Based on the references‟ teachings, the Examiner reasoned that an
ordinary artisan would have considered it obvious to include the clotting
material described by Weldon in “to hasten clotting [and] assist in
preventing further bleeding from the internal volume . . . . Once modified,
the free-flowing blood clotting material would be left in the internal volume
as a particulate material, from which the surface material had been removed
once the guidewires are pulled” (id. at 8-9).
We are not persuaded that the cited references would have suggested
the process recited in claim 11 to an ordinary artisan. Specifically, claim 11
requires the practitioner to remove the surface material of the inserted
flexible tube and thereby leave behind a volume of free-flowing blood
clotting material.
Claim 11 thus requires at least some free-flowing material to remain
behind after all of the surface material is removed. As the Specification
explains, this may be accomplished by retracting the surface material by
withdrawing wires attached to the material (see Spec. 9:11-15; see also Fig.
3).
The Examiner found that the resorption of the ECM (collagenous
extracellular matrix) material used as Obermiller‟s fistula plug corresponded
to the claimed removal step (see Ans. 8). The Examiner has not pointed to
any clear or specific evidence, however, suggesting that any clotting
material included in Obermiller‟s tube would still be free-flowing once all of
the ECM material was resorbed. Moreover, we are not persuaded that an
ordinary artisan would have considered it reasonable to interpret
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Obermiller‟s resorption as being within the meaning of the claimed removal
step, when viewing claim 11 in light of the Specification.
Thus, as we are not persuaded that the Examiner has adequately
explained why Obermiller and Weldon would have suggested a process
having the removing step required by claim 11 to an ordinary artisan, we
reverse the Examiner‟s obviousness rejection of that claim, and its
dependents, over those references.
OBVIOUSNESS – CLAGUE AND CRAGG
In rejecting claims 11 and 15 as obvious over Clague and Cragg the
Examiner cited Clague as describing a process substantially as recited in
claim 11, but conceded that Clague did not “expressly disclose the free
flowing material enclosed within the tube or the steps removing the surface
material of the tubing to leave a volume of free flowing blood clotting
material within the internal volume from which the surface has been
removed” (Ans. 9). The Examiner cited Cragg to address those deficiencies
(see id.).
Based on the references‟ combined teachings the Examiner concluded
that an ordinary artisan would have considered it obvious to modify
Clague‟s process to include “tubing and free-flowing blood clotting material
within and [the] step of removing the surface material to leave a volume of
free flowing blood clotting material, as taught by Cragg, in order to
effectively stop bleeding within the internal volume with the free flowing
blood clotting material (thrombin) and hydrated sponge” (id. at 9-10).
We reverse this rejection as well.
Like the technique used by Ashby discussed above, Cragg deploys its
clotting composition not in the form of a free-flowing material as required
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by claim 11, but rather as a sponge hydrated with the clotting material (see
Cragg, col. 6, ll. 18-37). We note, as the Examiner argues, that thrombin in
a fluid state is introduced into Cragg‟s sponge (see id. at col. 8, ll. 3-7).
As discussed above, however, we are not persuaded that the ultimate
material Cragg introduces into its patient – a sponge impregnated with fluid
– would reasonably be interpreted as a free-flowing material, particularly
when claim 11 is viewed in light of the Specification. We therefore reverse
the Examiner‟s obviousness rejection of claims 11 and 15 over Clague and
Cragg.

SUMMARY
We reverse each of the Examiner‟s rejections.

REVERSED

cdc