Ex Parte Gabbay

Board of Patent Appeals and Interferences

Mar 30, 2010

10266380 (B.P.A.I. Mar. 30, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte SHLOMO GABBAY
____________

Appeal 2009-002904
Application 10/266,380
Technology Center 3700
____________

Decided: March 30, 2010
____________

Before: LINDA E. HORNER, JENNIFER D. BAHR, and KEN B.
BARRETT, Administrative Patent Judges.

BAHR, Administrative Patent Judge.

DECISION ON APPEAL
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STATEMENT OF THE CASE
Shlomo Gabbay (Appellant) appeals under 35 U.S.C. § 134 (2002)
from the Examiner’s decision rejecting claims 2, 3, 5-19, 21, 22, 241, 27, and
28. Claims 23, 25, and 26 have been withdrawn from consideration by the
Examiner. Claims 1, 4, and 20 have been canceled. We have jurisdiction
over this appeal under 35 U.S.C. § 6 (2002).

The Invention
Appellant’s claimed invention is directed to a method of implanting
an implantable prosthetic device, particularly a heart valve prosthesis. Spec.
1:14-16.
Independent claim 5, reproduced below, is illustrative of the claimed
subject matter.
5. A method for implanting a heart valve
prosthesis into a patient's heart, the method
comprising:
inserting the heart valve prosthesis into a
barrel of an implanter, such that the prosthesis has
a reduced cross-sectional dimension relative to a
fully expanded cross-sectional dimension of the
prosthesis;
opening a patient's chest;
creating an opening in tissue located within
the open patient's chest to provide a substantially
direct path that extends from the opening to a
desired implantation site in the patient's heart, the
opening in the tissue being created in the patient's

1 Appellant’s omission of claims 2 and 24 in the listing of claims involved in
the appeal (App. Br. 4) is deemed to have been inadvertent, in light of
Appellant’s inclusion of claims 2 and 24 in the arguments (see App. Br. 19).
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pulmonary artery, the patient's aorta or heart
muscle of the patient so that the opening opposes
the desired implantation site;
passing a length of the barrel through the
opening in the tissue to position an end of the
barrel of the implanter adjacent the desired
implantation site in the patient's heart such that the
end of the barrel and the opening are along the
direct path;
discharging the heart valve prosthesis from
the barrel of the implanter adjacent the desired
implantation site; and
expanding the heart valve prosthesis at the
desired implantation site from the reduced cross-
sectional dimension toward the expanded cross-
sectional dimension, such that an exterior portion
of the heart valve prosthesis engages adjacent
tissue to mitigate movement of the prosthesis
relative to the adjacent tissue.

The Rejections
The Examiner relies upon the following as evidence of
unpatentability:
Giantureo US 5,035,706 Jul. 30, 1991
Stevens US 5,924,424 Jul. 20, 1999
Shokoohi US 6,077,296 Jun. 20, 2000
Liddicoat US 2002/0042651 A1 Apr. 11, 2002
Bailey US 6,458,153 B1 Oct. 1, 2002
Vesely WO 99/33414 Jul. 8, 1999

Appellant seeks review of the Examiner’s rejection under 35 U.S.C. §
102(e) of claims 2, 3, 5-7, 11, 24, and 27 as being anticipated by Liddicoat;
rejection under 35 U.S.C. § 102(b) of claims 12-14 and 18 as being
anticipated by Vesely; and rejections under 35 U.S.C. § 103(a) of claim 28
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as being unpatentable over Liddicoat; claims 8 and 10 as being unpatentable
over Liddicoat and Bailey; claim 9 as being unpatentable over Liddicoat,
Bailey, and Shokoohi; claims 15 and 16 as being unpatentable over Vesely
and Stevens; claims 17 and 19 as being unpatentable over Vesely and
Giantureo; and claims 21 and 22 as being unpatentable over Vesely and
Bailey.
The Examiner has withdrawn the rejections of claims 24 and 27 as
being anticipated by Vesely and of claim 28 as being unpatentable over
Vesely. Ans. 11.

SUMMARY OF DECISION
We REVERSE.

OPINION
Rejections based on Liddicoat
Independent claim 5 requires a step of creating an opening in tissue to
provide “a substantially direct path that extends from the opening to a
desired implantation site . . . so that the opening opposes the desired
implantation site.” Independent claim 24 requires a step of creating an
opening such that a desired implantation site in the patient’s heart is “in a
line of sight with the opening.” Each of these claims further calls for placing
a heart valve prosthesis into a barrel or cylindrical enclosure of an implanter,
passing a portion of the barrel or cylindrical enclosure through the opening,
discharging the heart valve prosthesis from the barrel or cylindrical
enclosure either adjacent or at the desired implantation site, and expanding
the heart valve prosthesis at the implantation site. The Examiner found that
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Liddicoat describes creating an opening having such a relationship with the
implantation site.
Appellant argues that Liddicoat discloses a path from the tissue
opening (atriotomy 10) to the implantation site that is very indirect, and thus
is not “a substantially direct path . . . so that the opening opposes the desired
implantation site,” as called for in claim 5. App. Br. 14-16. For the same
reason, according to Appellant, Liddicoat fails to disclose creating an
opening such that a desired implantation site is in a line of sight with the
opening, as called for in claim 24. App. Br. 20-24. Thus, at issue in this
appeal is whether Liddicoat satisfies these limitations of claims 5 and 24.
We begin by construing the claim limitations at issue. When claim
terminology is construed in the United States Patent and Trademark Office,
claims are to be given their broadest reasonable interpretation consistent
with the specification, reading claim language in light of the specification as
it would be interpreted by one of ordinary skill in the art. In re Am. Acad. of
Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004).
We find that ordinary and customary usages of the term “direct”
include “by the shortest way, without turning or stopping; not roundabout;
not interrupted; straight.” Webster's New World Dictionary 399 (David B.
Guralnik ed., 2nd Coll. Ed., Simon & Schuster, Inc. 1984).
The term “substantially” has been construed in patent claims as
largely but not wholly that which is specified. See, e.g., York Prods., Inc. v.
Cent. Tractor Farm & Family Ctr., 99 F.3d 1568, 1572-73 (Fed. Cir. 1996);
see also Amhil Enter. Ltd. v. Wawa, Inc., 81 F.3d 1554, 1562 (Fed. Cir.
1996) (construing “substantially vertical,” in light of the intrinsic evidence,
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as meaning the same as or very close to vertical, and as referring to a
deviation only slightly, if at all, from vertical).
The “simplified and efficient method” embodiments of Appellant’s
invention described as being “under substantially direct vision of the
surgeon” and providing “a substantially direct and linear path to the desired
implantation position” are depicted in figures 22-24. See Spec. 25:20-22 and
27:19-25. In each of these figures, the incision through which the barrel of
the implanter is inserted is located so that the barrel can be inserted to a
position in which its distal end is at or adjacent the implantation site at
which the valve prosthesis will be secured without making any sharp turns.
As depicted in figures 22 and 23, the barrel is inserted to the implantation
position in a straight line, and as depicted in figure 24, the barrel is inserted
in a generally, but not wholly, straight line.
In light of the disclosure in Appellant’s Specification and drawings,
we construe “substantially direct path” as denoting a path that approximates
a straight line, without any sharp turns.
We find that Liddicoat describes a method wherein the prosthetic
valve 200 is secured to the distal end of a first manipulation instrument 400
and inserted through an opening (atriotomy 10) into the left atrium (fig. 1);
passed through the mitral valve 30 into the left ventricle 25 (fig. 2);
transferred to the distal end of a second manipulation instrument 500
inserted into the aorta 20 via an incision 35, which is small compared to
atriotomy 10 (figs. 3 and 4); positioned in the implantation position (fig. 6);
and secured in place, using barbs or staples 700, or other means (fig. 7). See
paras. 47, 56, 57, 59-61, and 67. The path described by Liddicoat from the
atriotomy 10 (the insertion opening for the prosthetic valve) to the
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implantation position, shown in figures 6 and 7, begins in the left atrium,
passes downwardly through the mitral valve, takes a sharp turn, and then
continues up into the aorta. This path is not straight, so that the opening
opposes the desired implantation site, and does not place the implantation
site or position in a line of sight with the atriotomy 10, as the walls dividing
the left atrium, left ventricle, and aorta interrupt any such line of sight.
Further, Liddicoat locates the prosthetic valve insertion opening (atriotomy
10, which must be larger than aortic incision 35 because it must
accommodate the prosthetic valve) in the left atrium, remote from the aorta,
because the pressure of blood flowing through the left atrium is very low,
thereby lowering the risk of uncontrollable bleeding, and because the left
atrium rarely suffers from plaque formation or calcification, thus minimizing
the risk of embolic debris during the incision. Para. 30. Liddicoat broadly
mentions the possibility of performing the disclosed procedure using a single
manipulation instrument technique, but emphasizes that such a single
manipulation instrument must be capable of deflecting its tip by an angle of
between about 90 and 180 degrees from the long axis of the first
manipulation instrument 400 so as to traverse the path depicted in figures 1-
7.
Based on our findings above, Liddicoat satisfies neither the step of
claim 5 of creating an opening in tissue to provide “a substantially direct
path that extends from the opening to a desired implantation site . . . so that
the opening opposes the desired implantation site,” nor the step of claim 24
of creating an opening such that a desired implantation site in the patient’s
heart is “in a line of sight with the opening.”
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While the Examiner correctly notes that “substantially” is a term of
degree (Ans. 4), the Examiner’s attempt to read the “substantially direct
path” limitation on Liddicoat’s path, requiring a sharp turn of over 90
degrees, is unreasonably broad, in light of Appellant’s Specification and
drawings. Likewise, the Examiner’s position that “the implantation site
could be considered the point of entry” (Ans. 9) is untenable. The
“implantation site” is the location at which the valve prosthesis is implanted,
that is, secured to the tissue. Any notion that a modifier, such as “‘final’”
(see Ans. 9) would be required to convey what is meant by “implantation
site” is unreasonable.
Accordingly, we reverse the rejection of independent claims 5 and 24,
and their dependent claims 2, 3, 6, 7, 11, and 27, as being anticipated by
Liddicoat. The Examiner does not point to any teaching in Bailey or
Shokoohi which would make up for the deficiency in Liddicoat discussed
above, or articulate any reason why it would have been obvious to modify
Liddicoat so as to overcome this deficiency. Thus, we also reverse the
rejections of claim 28 as being unpatentable over Liddicoat; claims 8 and 10
as being unpatentable over Liddicoat and Bailey; and claim 9 as being
unpatentable over Liddicoat, Bailey, and Shokoohi.
Rejections based on Vesely
Independent claim 12 requires a step of creating an opening in tissue
to provide “a substantially linear path extending along a line of sight from
the opening to a desired implantation position.” Independent claim 18
requires a step of creating an opening in tissue that provides “a linear path
extending from the opening to a desired implantation position.”
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Appellant argues that Vesely describes an implantation method in
which the delivery catheter is inserted into a femoral artery or other large
vessel that is remote from the implantation site, such that the path from the
insertion opening to the implantation site is not “a substantially linear path
extending along a line of sight from the opening to a desired implantation
position,” as called for in claim 12, and is not “a linear path extending from
the opening to a desired implantation position,” as called for in claim 18.
App. Br. 24-25 and 30-31.
The Examiner asserts that “[i]t can be said the catheter [of Vesely] has
a linear dimension and thus the prosthesis follows a ‘linear path.’” Ans. 5.
Further, the Examiner contends that Vesely’s disclosure of insertion through
an artery or other large vessel could be interpreted as disclosure of an artery
such as the pulmonary or aorta. Id. With respect to claim 12, the Examiner
asserts that the use of the term “substantially” to modify “linear” permits a
“relatively unlimited” interpretation of “substantially linear path.” Ans. 5.
For the reasons discussed above, the construction of “substantially
linear path” as “relatively unlimited” advanced by the Examiner is not
reasonable in light of Appellant’s underlying disclosure. We find nothing in
Appellant’s Specification or drawings which permits a broader construction
of “substantially linear” than approximating linear.
We find that Vesely describes a system for “minimally invasive
removal and re-insertion of a bioprosthetic heart valve.” P. 3, ll. 29-30.
According to Vesely, the heart valve must be sufficiently collapsible “to be
able to pass through the lumen of a catheter inserted into the femoral artery,
or other large vessel.” P. 3, l. 31 to p. 4, l. 1. Vesely further describes an
inflatable or distensible surgical platform 50 which can be delivered to a site
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near the heart in a collapsed state and distended such that it anchors the
numerous catheters and devices to ensure “proper controlled manipulation of
their distal ends, when acted upon by controls at their proximal ends.” P. 4,
ll. 18-22 and p. 13, ll. 9-12. Additionally, Vesely characterizes the
implantation procedure as “[c]omplex, remote surgery” requiring “a suitable
device tracking and visualization system,” comprising “ultrasound imaging,
continuous X-ray fluoroscopy, or some combination of both.” P. 15, ll. 13-
14 and 20-21. While Vesely describes anchoring the distal end of the
delivery system in the ascending aorta via the surgical platform 50 (p. 13, ll.
10-12), the Examiner has pointed to no teaching in Vesely of inserting a
valve prosthesis into a cylindrical barrel or enclosure passed through an
opening in tissue in the ascending aorta. The Examiner likewise has not
pointed to, and we do not find, any description in Vesely of the path from
the incision made for passage of the delivery system to the implantation site.
Anticipation is established only when a single prior art reference
discloses, expressly or under the principles of inherency, each and every
element of a claimed invention. RCA Corp. v. Applied Digital Data Sys.,
Inc., 730 F.2d 1440, 1444 (Fed. Cir. 1984). Under principles of inherency,
when a reference is silent about an asserted inherent characteristic, it must be
clear that the missing descriptive matter is necessarily present in the thing
described in the reference, and that it would be so recognized by persons of
ordinary skill. Cont’l Can Co. v. Monsanto Co., 948 F.2d 1264, 1268 (Fed.
Cir. 1991).
As shown by our findings above, the Examiner has not established
either that Vesely explicitly teaches a “linear” or “substantially linear” path
from the incision through which the delivery catheters are inserted to the
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implantation position, or that a person of ordinary skill in the art would have
recognized the procedure described by Vesely as comprising a “linear” or
“substantially linear” path from the incision to the implantation position.
Thus, we reverse the rejection of claims 12 and 18, as well as claims 13 and
14 depending from claim 12, as being anticipated by Vesely.
The Examiner has not advanced any reasoning as to why it would
have been obvious to modify Vesely to make up for the deficiency noted
above, or pointed to any teaching in any of Stevens, Giantureo, and Bailey
which would make up for this deficiency. Thus, we also reverse the
rejections of claims 15 and 16 as being unpatentable over Vesely and
Stevens; claims 17 and 19 as being unpatentable over Vesely and Giantureo;
and claims 21 and 22 as being unpatentable over Vesely and Bailey.

DECISION
The Examiner’s decision is reversed.

REVERSED

hh

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