Ex Parte PIERSON et al

Patent Trial and Appeal Board

May 18, 2016

12724574 (P.T.A.B. May. 18, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/243,256 10/01/2008 Oscar H. Frazier
23505 7590 05/04/2016
CONLEY ROSE, P.C.
Jonathan M. Harris
1001 Mckinney
Suite 1800
HOUSTON, TX 77002-6417
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
2866-00101 9945
EXAMINER
PHAM, MINH DUC GIA
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
05/04/2016 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):
pathou@conleyrose.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte OSCAR H. FRAZIER and WILLIAM E. COHN1
Appeal2014-004166
Application 12/243,256
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
PER CURIAM
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to an
intraatrial ventricular assist device. The claims are rejected as anticipated
and obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 According to Appellants, the Real Party in Interest is Minvasc Devices,
LLC (App. Br. 3).
Appeal2014-004166
Application 12/243,256
STATEMENT OF THE CASE
Appellants' invention relates to devices for assisting ventricular
function of a heart having an outflow conduit that passes through the atrial
septum and purports to forgo the need for a pocket outside of the heart
(Spec. i-f 3). Claims 1, 3-13, and 25 are on appeal. Claim 1 is illustrative
and reads as follows (emphasis added):
1. A medical device comprising:
a pump configured to fit entirely within one or more atrial
chambers of a heart, said pump comprising an inlet and an outlet,
the pump also comprising an expandable collar to secure the
pump to an atrial septum; and
a flexible outflow conduit coupled to said outlet and
having a length sufficient to extend from the right atrium and
coaxially through the superior vena cava and subclavian vein,
and into the subclavian artery;
wherein said pump pumps oxygenated blood from the left
atrium through the outflow conduit in a direction in the superior
vena cava counter to the direction of deoxygenated blood in the
superior vena cava returning to the heart.
The claims stand rejected as follows:
I. Claims 1, 3, 4, 6, 9-12, and 25 stand rejected under 35 U.S.C.
§ 102( e) as being anticipated by Wampler. 2
II. Claim 5 stands rejected under 35 U.S.C. § 103(a) as being
obvious based on Wampler.
III. Claims 7, 8, and 13 stand rejected under 35 U.S.C. § 103(a) as
being obvious based on Wampler and Aboul-Hosn.3
2 Wampler, US 2009/0149950 Al, published June 11, 2009.
3 Aboul-Hosn, US 2006/0155158 Al, published July 13, 2006.
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Appeal2014-004166
Application 12/243,256
I.
The Examiner has rejected claims 1, 3, 4, 6, 9-12, and 25 under
35 U.S.C. § 102(e) as being anticipated by Wampler. We focus our
discussion on independent claims 1 and 25.
Findings of Fact
FF 1. Wampler discloses
A heart assist device comprising a rotary pump housing
having a cylindrical bore, a pumping chamber and a motor stator
including an electrically conductive coil located within the
housing and surrounding a portion of the cylindrical bore. A
rotor has a cylindrical shaft, at least one impeller appended to
one end of the shaft, and a plurality of magnets located within
the shaft .... The relative orientation of positions of the inflow,
outflow, and leakage flow paths may be varied within the pump,
such as to accommodate different intended methods for
implantation and/or use.
(Wampler Abstract; see also Final Act. 2-3.)
FF 2. vVampler depicts in Figure 3A a schematic view of placement
of a ventricular assist system having a pump (Wampler i-f 66). Figure 3A is
reproduced below.
,.-so
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Appeal2014-004166
Application 12/243,256
(Id. at Fig. 3A.) Figure 3A shows "a pump system 50 with a pump 52 that is
positioned in a left ventricle 4 and with an outlet cannula 56 that is passed
antegrade through the aortic valve 6" (id. at i-f 99; see also Final Act. 2).
FF 3. Wampler discloses that "the outflow graft could be tunneled to
the subclavian or femoral artery for anastomosis. A pump is then placed
between the inflow and outflow grafts such that blood is removed from the
left ventricle and pumped into the systemic circulation" (Wampler i-f 104;
see also id. at i-f 119, Final Act. 3, Ans. 3).
FF 4. Wampler discloses that "the inflow cannula or pump is secured
using a stabilizing device which either comprises a polymeric or elastomeric
washer, or which employs a collar button shape. The stabilizer is optimized
to capture the implanted cannula or pump and also has features that can be
sutured, stapled or bonded to the chamber wall to secure the cannula or
pump" (Wampler i-f 175; see also Final Act. 2-3).
FF 5. Wampler depicts in Figure 23B a schematic view of a
cooperating component device for implantation a blood pump within a left
ventricle (Wampler i-f 86). Figure 23B is reproduced below.
(Id. at Fig. 23B.) Figure 23B shows that "[a]n expandable traction device
458 is placed through the introducer 450 into the heart chamber 456 and
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Appeal2014-004166
Application 12/243,256
deployed to permit a traction force 460 to be applied to the insertion site 454
in the direction shown, thus stabilizing and controlling the heart wall 452"
(id. at i-f 176; see also Final Act. 3).
Analysis
Claims 1, 3, 4, 6, and 9-12
We have considered, but do not find persuasive, Appellants'
arguments that the Examiner erred in finding that Wampler anticipates
claim 1. We address Appellants' arguments below.
Appellants contend that, as evidenced by Figure 3A, Wampler does
not disclose a cannula having a sufficient length to extend from the right
atrium to the subclavian artery (App. Br. 12; Reply Br. 1-2).
We are not persuaded. We agree with the Examiner that Wampler
discloses extending the pump's outflow to the subclavian artery (Ans. 3; see
FF 3 ("the outflow graft could be tunneled to the subclavian or femoral
artery for anastomosis.").
Appellants contend that Wampler does not disclose the claim
limitation "wherein said pump pumps oxygenated blood from the left atrium
through the outflow conduit in a direction in the superior vena cava counter
to the direction of deoxygenated blood in the superior vena cava returning to
the heart" (App. Br. 14).
We are not persuaded. We agree with the Examiner that this claim
phrase constitutes a functional limitation, as it defines the pump by what it
does, rather than what it is (see Ans. 4). "A patent applicant is free to recite
features of an apparatus either structurally or functionally. . . . Yet, choosing
to define an element functionally, i.e., by what it does, carries with it a risk."
In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997). "'Functional'
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Appeal2014-004166
Application 12/243,256
terminology may render a claim quite broad. Ry its own literal terms a
claim employing such language covers any and all embodiments which
perform the recited function." In re Swinehart, 439 F.2d 210, 213
(CCP A 1971 ). Accordingly, we conclude that claim 1 requires a pump that
is capable of pumping oxygenated blood from the left atrium through the
outflow conduit in a direction in the superior vena cava counter to the
direction of deoxygenated blood in the superior vena cava returning to the
heart.
We agree with the Examiner that "Wampler satisfies each and every
structural feature required in claim 1, as both pumps comprise an inlet, an
outlet, and an element to secure the pump to the chamber wall," and further
that Wampler's device is capable of performing the recited function of
pumping oxygenated blood from the left atrium through the outflow conduit
in a direction in the superior vena cava counter to the direction of
deoxygenated blood in the superior vena cava returning to the heart (Ans. 4;
FF 1-5).
Appellants argue that Wampler "states that it is impractical to use the
subclavian or femoral artery for insertion of a transvalvular cannula from a
pump" and therefore, teaches away from Appellants' approach (Reply Br.
3). However, we note that the Federal Circuit has determined that
"[t ]eaching away is irrelevant to anticipation." Seachange Int 'l, Inc., v. C-
COR, Inc., 413 F.3d 1361, 1380 (Fed. Cir. 2005). "A reference is no less
anticipatory if, after disclosing the invention, the reference then disparages
it. Thus, the question whether a reference 'teaches away' from the invention
is inapplicable to an anticipation analysis." Celeritas Technologies, Ltd. v.
Rockwell Intern. Corp., 150 F.3d 1354, 1361 (Fed. Cir. 1998).
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Application 12/243,256
We therefore affirm the rejection of claim 1 as anticipated by
Wampler. Claims 3, 4, 6, and 9-12 fall with claim 1.
Claim 25
We agree with Appellants that the Examiner erred in rejecting claim
25 as being anticipated by Wampler.
Claim 25 recites, in pertinent part, "a continuous flow pump
configured to fit across an atrial septal wall separating a left atrial chamber
from a right atrial chamber of a heart, ... "
We agree with the Examiner that this claim phrase constitutes a
functional limitation (see Ans. 4). Accordingly, we conclude that claim 25
requires a pump that is capable of fitting across an atrial septal wall
separating a left atrial chamber from a right atrial chamber of a heart.
Nevertheless, we disagree with the Examiner's conclusion that
Wampler's pump is capable of this function.
While Wampler discloses a pump that is positioned in a left ventricle
(FF 2) and an expandable traction device that is placed into the heart
chamber to stabilize and control the heart wall (FF 5), the Examiner does not
demonstrate that Wampler' s pump has sufficient width, dimensions, or
capability of being fitted across an atrial septal wall separating the left atrial
chamber from the right atrial chamber (Final Act. 2-3, Ans. 4; see also FF
1-5).
II.
The Examiner has rejected claim 5 under 35 U.S.C. § 103(a) as being
obvious over Wampler. Appellants present no additional argument based on
the teachings of Wampler, and rely on the same arguments addressed above
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Application 12/243,256
with regard to Wampler (see App. Rr. 14). For the reasons discussed above,
therefore, we affirm the rejection of claim 5.
II.
The Examiner has rejected claims 7, 8, and 13 under 35 U.S.C.
§ 103(a) as being obvious over Wampler and Aboul-Hosn. Appellants
present no additional argument based on the teachings of Aboul-Hosn, and
rely on the same arguments addressed above with regard to Wampler (see id.
at 15). For the reasons discussed above, therefore, we affirm the rejection of
claims 7, 8, and 13.
SUMMARY
We affirm the rejection of claim 1under35 U.S.C. § 102(e) based on
Wampler. Claims 3, 4, 6, and 9-12 fall with claim 1.
We reverse the rejection of claim 25 under 35 U.S.C. § 102(e) based
on Wampler.
We affirm the rejection of claim 5 under 35 U.S.C. § 103(a) based on
Wampler.
We affirm the rejection of claims 7, 8, and 13 under 35 U.S.C. §
103(a) based on Wampler and Aboul-Hosn.
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)(l )(iv).
AFFIRMED-IN-PART
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