Ex Parte Acosta et al

Board of Patent Appeals and Interferences

Mar 5, 2012

11217648 (B.P.A.I. Mar. 5, 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.
11/217,648 09/01/2005 George M. Acosta VTLZ 200002US02 8542
27885 7590 03/06/2012
FAY SHARPE LLP
1228 Euclid Avenue, 5th Floor
The Halle Building
Cleveland, OH 44115
EXAMINER
MATTHEWS, WILLIAM H
ART UNIT PAPER NUMBER
3774
MAIL DATE DELIVERY MODE
03/06/2012 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 GEORGE M. ACOSTA and GEORGE F. KICK
____________

Appeal 2010-007287
Application 11/217,648
Technology Center 3700
____________

Before JENNIFER D. BAHR, LINDA E. HORNER, and
WILLIAM V. SAINDON, Administrative Patent Judges.

HORNER, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
George M. Acosta and George F. Kick (Appellants) seek our review
under 35 U.S.C. § 134 of the Examiner’s decision rejecting claims 17, 18,
41, 45, 46, 48, 56-59, and 61-63. Claims 11-13 and 50 are withdrawn and
claims 1-10, 14-16, 19-40, 42-44, 47, 49, 51-55, and 60 are canceled. We
have jurisdiction under 35 U.S.C. § 6(b). We REVERSE.
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Application 11/217,648

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THE INVENTION
Appellants’ claimed invention relates to “a synthetic or artificial
prosthetic valve device for implantation in a blood vein.” Spec. 1, ll. 11-12.
Claim 41, reproduced below, is representative of the subject matter on
appeal.
41. A venous valve prosthesis comprising:
pliable leaflet members configured to move back and
forth between an open position allowing blood flow in a
forward direction, and a closed position substantially blocking
blood backflow;
a hollow and generally cylindrical support member
retaining the leaflet members thereon; and
an aperture defined in at least one of the leaflet members
such that blood may backflow through the aperture when the
leaflets are in the closed position, the aperture allowing a small
amount of blood to backflow when the valve is in the closed
position so that the closed valve cannot completely stop blood
flow in the closed position.
THE EVIDENCE
The Examiner relies upon the following evidence:1
Davis US 4,192,020 Mar. 11, 1980
Gabbay US 4,759,758 Jul. 26, 1988
MacGregor US 4,936,317 Jun. 26, 1990
Cosgrove US 5,800,531 Sep. 1, 1998
Quijano US 5,824,061 Oct. 20, 1998
Evdokimov US 5,861,029 Jan. 19, 1999

1 The Examiner lists U.S. Patent 5,861,028 to Angell in the “Evidence
Relied Upon” section of the Answer, but does not cite this reference in any
of the grounds of rejection on appeal. Ans. 3.
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THE REJECTIONS
Appellants seek review of the following rejections:
1. Claims 17, 18, 41, 59, and 61-63 under 35 U.S.C. § 103(a) as
unpatentable over Quijano and Evdokimov.
2. Claims 45 and 48 under 35 U.S.C. § 103(a) as unpatentable over
Quijano, Evdokimov, and Gabbay.
3. Claim 46 under 35 U.S.C. § 103(a) as unpatentable over Quijano,
Evdokimov, and MacGregor.
4. Claims 56-58 under 35 U.S.C. § 103(a) as unpatentable over Quijano,
Evdokimov, and Davis.
ISSUE
The Examiner determined that it would have been obvious to modify
the venous valve prosthesis of Quijano to include an aperture as taught by
Evdokimov “to prevent thrombus formation.” Ans. 3-4.
Appellants argue that one of ordinary skill in the art would not have
been led to the proposed modification because “Quijano already addresses
thrombus formation by preserving the smooth natural luminal diameter” and
neither Quijano nor Evdokimov would have led one to “mentally transform
the clearance formed in Evdokimov’s mechanical hinge into an aperture in,
or passing through, a natural venous valve leaflet.” Reply Br. 5-6.
The issue presented by this appeal is whether the Examiner articulated
adequate reasoning based on rational underpinnings to explain why one of
ordinary skill in the art would have been led by Evdokimov to modify the
natural leaflets of Quijano’s valve to include an aperture.
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Application 11/217,648

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ANALYSIS
Independent claim 41 calls for a venous valve prosthesis comprising
“pliable leaflet members” and “an aperture defined in at least one of the
leaflet members such that blood may backflow through the aperture when
the leaflets are in the closed position.” Independent claims 59 and 61
similarly call for a venous valve prosthesis comprising “pliable leaflet
members” and “one or more openings passing through at least one” leaflet
member.
The Examiner acknowledged that Quijano does not disclose a valve
leaflet including an aperture or opening. Ans. 3. Quijano discloses that
thromboembolic complications due to non-laminar or turbulent flow can be
brought about by abrupt variation in lumenal diameter. Col. 2, ll. 51-56.
Quijano solves this problem by using an exovascular stent device and
dilation restrictor members for facilitating implantation and functioning of
venous grafts having functioning venous valves therein. Col. 3, ll. 8-14 and
col. 6, ll. 57-65. Quijano also discloses an optional spacer ring located
between the tissue of the blood vessel and the tissue of the prosthetic
vascular graft should have a central aperture with the same inner diameter as
the flange end opening of the dilation restrictor member and the end
openings of the exovascular stent member to prevent or minimize the
likelihood of excessive turbulence or non-laminar flow within the blood
vessel due to excessive variations of inner diameter of the blood vessel.
Col. 7, ll. 27-51.
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Evdokimov relates to an artificial heart valve prosthesis and teaches
that “to decrease the risk of thrombus formation one has to eliminate blood
stagnation zones, ensure laminar blood flow and provide good washing of all
elements of the valve.” Col. 1, ll. 3, 40-43. Evdokimov discloses that in the
case of a heart valve prosthesis having leaflets connected to the valve body
by hinge mechanisms, “there is a large blood stagnation zone in the hinge
regions” and “[t]he absence of washing by blood flow in regions adjacent to
hinges leads to higher risks of thrombus formation exactly at these places.”
Col. 2, ll. 17-18, 23-25. Evdokimov suggests solving this problem by
providing a channel in one of the leaflets at the contact surface of the leaflet
to allow a restricted blood backflow when the leaflets are in the closed
position. Col. 5, l. 56 – col. 6, l. 32, and col. 10, ll. 1-10.
We are not persuaded that one of ordinary skill in the art would have
been led by the teaching in Evdokimov, which teaches using a channel in the
leaflet of an artificial heart valve prosthesis to prevent thrombus formation in
the hinge regions, to add an aperture in at least one leaflet in the natural
venous valve of Quijano. Quijano solves the problem of thrombus
formation by avoiding excessive variations in the inner diameter of the blood
vessel. As such, we cannot find by a preponderance of the evidence that one
of ordinary skill in the art would be concerned with thrombus formation in
the valve of Quijano. Because Quijano uses a natural venous valve, it does
not have similar hinge regions as the artificial valve of Evdokimov, and thus
does not encounter the problem of blood stagnation at such hinge regions.
The Examiner speculated that Quijano “includes various locations which
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Application 11/217,648

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could be susceptible to stagnation zones.” Ans. 7-8 (showing annotated
Figure 16 of Quijano to illustrate potential stagnation zones at the points of
connection of the stent 10 and restrictor members 30). Even if blood
stagnation were to occur at the points of connection of the stent 10 and
restrictor members 30, Evdokimov is directed to preventing blood stagnation
at a hinge region and does not suggest that use of backflow through
apertures formed in Quijano’s leaflets would prevent stagnation at the
location identified by the Examiner. In other words, even if one of ordinary
skill in the art were concerned generally with thrombus formation, due to the
differences in valves used in Evdokimov and Quijano, we cannot find by a
preponderance of the evidence that Evdokimov would have led one to add
an aperture in the leaflet of Quijano’s natural valve. As such, we do not
sustain the rejection of independent claims 41, 59, and 61 or their dependent
claims 17, 18, 62, and 63 over Quijano and Evdokimov.
The remaining rejections rely on the base combination of Quijano and
Evdokimov in view of additional teachings of Gabby, MacGregor, and
Davis. The Examiner does not rely on the additional references to cure the
noted deficiencies in the base combination of Quijano and Evdokimov. See
Ans. 4-5. As such, for the same reasons discussed supra, we do not sustain
the rejections under 35 U.S.C. § 103 of claims 45 and 48 in view of Quijano,
Evdokimov, and Gabbay; claim 46 in view of Quijano, Evdokimov, and
MacGregor; or claims 56-58 in view of Quijano, Evdokimov, and Davis.
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CONCLUSION
The Examiner did not articulate adequate reasoning based on rational
underpinnings to explain why one of ordinary skill in the art would have
been led by Quijano and Evdokimov to modify the natural leaflets of
Quijano’s valve to include an aperture.
DECISION
The decision of the Examiner to reject claims 17, 18, 41, 45, 46, 48,
56-59, and 61-63 is REVERSED.

REVERSED

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