Ex Parte Wittens

Board of Patent Appeals and Interferences

May 20, 2010

10181703 (B.P.A.I. May. 20, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte CORNELIS HENDRIKUS ANNA WITTENS
____________

Appeal 2009-006403
Application 10/181,703
Technology Center 3700
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Decided: May 20, 2010
____________

Before: LINDA E. HORNER, WILLIAM F. PATE III, and KEN B.
BARRETT, Administrative Patent Judges.

HORNER, Administrative Patent Judge.

DECISION ON APPEAL
Appeal 2009-006403
Application 10/181,703

STATEMENT OF THE CASE
Cornelis Hendrikus Anna Wittens (Appellant) seeks our review under
35 U.S.C. § 134 of the Examiner’s decision rejecting claims 11, 12, and 17,
which are all of the claims on appeal.1 App. Br. 2. We have jurisdiction
under 35 U.S.C. § 6(b). We reverse.
THE INVENTION
Appellant’s claimed invention is an implant valve for implantation in
a blood vessel. Spec. 1:1-2. Claim 11, reproduced below, is representative
of the subject matter on appeal.
11. An implant valve for implantation in a blood vessel,
comprising:
a flexible tube; and
a hollow, substantially cylindrical support extending over
a part of a length of the flexible tube substantially coaxially
along a wall of the tube, the support comprising a casing that is
expandable in diameter from an initial position to an
implantation position having an expanded diameter that causes
the tube to contact an inner wall of the blood vessel, wherein
the casing when expanded to the implantation position
comprises:
a first portion that supports a first part of the tube to
provide a shell for clamping substantially coaxially along the
inner wall of the blood vessel; and
a second portion that configures a second, axially
contiguous part of the tube to provide a flexible, tubular valve
body, which in use extends substantially clear of the inner wall
of the blood vessel;
wherein the support includes an axially extending finger-
shaped extension configured to support at least a portion of an

1 Claims 13-16 and 18 are objected to as dependent upon a rejected base
claim (independent claim 11), but would be allowable if rewritten in
independent form, to include the limitations of the base claim. Ans. 2.
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inner wall of the second part of the tube that forms the flexible,
tubular valve body, and wherein the flexible, tubular valve body
formed from the flexible tube by the second portion of the
casing is configured to allow blood to pass through in a first
direction and to collapse so as to restrict passage of blood in a
second direction opposite the first direction.
THE REJECTIONS
Appellant seeks review of the following rejections by the Examiner:
1. Rejection of claims 11 and 12 under 35 U.S.C. § 102(b) as anticipated
by Love (US 4,470,157).
2. Rejection of claims 11 and 12 under 35 U.S.C. § 103(a) as
unpatentable over Love and either Black (US 4,490,859), or McNeil (US
4,638,544), or Gabbay (US 4,759,758).
3. Rejection of claim 17 under 35 U.S.C. § 103(a) as unpatentable over
Love, and either Black, or McNeil, or Gabbay, and Donlon (US 6,010,531).
ISSUES
The Examiner found Love discloses all aspects of the invention of
claims 11 and 12 based in part on a finding that Love’s valve is inherently
“expandable in diameter from an initial position to an implantation position
having an expanded diameter,” as called for in independent claim 11,
because it is fabricated of Delrin. Ans. 4 (citing to Black, Gabbay, or
McNeil as evidence of Delrin’s flexibility and expandability). Alternatively,
the Examiner concluded a person of ordinary skill in the art would have
modified Love’s valve to be expandable, as called for in independent claim
11, for the same reasons that Black, Gabbay, and McNeil utilize Delrin.
Ans. 4-5.
Appellant argues Love does not anticipate claims 11 and 12 because
Love does not disclose stents that are inherently expandable. App. Br. 7-8;
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Reply Br. 1-2. Appellant further argues that claims 11 and 12 are patentable
over Love, Black, Gabbay, and McNeil, because the Examiner has not
provided an adequate rationale to explain why a person of ordinary skill in
the art would modify Love’s valve to be expandable as called for in claim
11. App. Br. 9; Reply Br. 2-3.
The issues before us are:
Is Love’s valve inherently “expandable in diameter from an initial
position to an implantation position having an expanded diameter,” as called
for in independent claim 11?
Is the proposed combination based upon a sufficient reason with a
rational underpinning to explain why a person of ordinary skill in the art
would have modified Love’s valve to reach the subject matter of claim 11?
The Examiner found that Donlon discloses inserting aortic tricuspid
valves, such as that disclosed by Love, percutaneously in order to make the
procedure less invasive. Ans. 5. The Examiner concluded that it would
have been obvious in light of the teaching in Donlon to a person of ordinary
skill in the art to further modify the proposed combination of Love, and
either Black, or Gabby, or McNeil, recited in the rejection of claim 11, to
implant Love’s modified valve percutaneously to make the procedure less
invasive.
Appellant argues that the method of claim 17 requires the diameter of
the casing to be brought from an initial position to an implantation position
so that the rejection of claim 17 fails for the same reasons as the rejection of
claim 11. App. Br. 10; Reply Br. 4.
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The issue before us is:
Does the proposed combination include a valve that can be brought
from an initial to an implantation position as called for in claim 17?
FINDINGS OF FACT
We find that the following enumerated facts are supported by at least
a preponderance of the evidence. Ethicon, Inc. v. Quigg, 849 F.2d 1422,
1427 (Fed. Cir. 1988) (explaining the general evidentiary standard for
proceedings before the Office).
1. Love discloses a method and apparatus for providing a tricuspid
tissue type prosthetic heart valve 10 assembled from the patient’s
autogenous tissue, comprised of an inner stent 11, tissue cylinder
13, and outer stent 12. Love, col. 1, ll. 11-13; col. 2, ll. 61, 64-67;
figs. 1-4.
2. Love discloses stents 11 and 12 are cylinders each having an
annular base 14 and 17, respectively, at one end, and three pointed
peaks 15 and 16, respectively, spaced 120 degrees apart at the
opposite end (describing this end as “scalloped”). Love, col. 3,
ll. 12-19. Base 17 of outer stent 12 includes a flexible flange 18
used to sew the assembled valve 10 to the patient’s heart. Love,
col. 3, ll. 19-21. Stents 11 and 12 are preferably made of Delrin, a
thermoplastic acetal resin, and are covered with a cloth or fabric,
such as Dacron. Love, col. 3, ll. 3-5.
3. Love discloses the Delrin of stents 11 and 12 is thermobonded to
the Dacron cloth by applying heat and pressure to the fabric over
the stents to a temperature above the melting point of Delrin but
below the melting point of Dacron so that the Delrin melts and
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flows into the interstices of the fabric. Love, col. 3, ll. 5-9. The
thermobonding may be done uniformly or only at selected spots.
Love, col. 3, ll. 9-11.
4. Love discloses tissue cylinder 13 is formed to have an inner
diameter closely matching the outer diameter of inner stent 11.
Love, col. 3, ll. 22-30; fig. 1.
5. Love discloses valve 10 is assembled by slipping tissue cylinder 13
around inner stent 11, and then placing outer stent 12 over tissue
cylinder 13 so that peaks 15 of inner stent 11 and peaks 16 of outer
stent 12 align with each other. Love, col. 3, ll. 32-33, 36-38; figs.
2, 3.
6. Love discloses that stents 11 and 12 are prefabricated in a variety
of sizes to permit selection of a size best fitting a patient. Love,
col. 3, ll. 1-3.
7. Black discloses a bioprosthetic bicuspid or tricuspid mitral valve
having a flexible frame 1 and ring shaped base 2 formed of Delrin
polymer with differential flexibility afforded by differing
thicknesses of Delrin in the base 2. Black, col. 1, ll. 4-8; col. 2, ll.
33-37; col. 3, ll. 20-28; figs. 1, 6, 7. Black discloses the frame 1
and base 2 are covered with Dacron cloth 5 (col. 2, ll. 33-35), but it
does not discuss the properties of Delrin thermobonded to Dacron.
Black, passim.
8. Gabbay discloses a prosthetic heart valve that includes a support
body or stent 1 “made of a flexible material, preferably a plastic
such as Delrin.” Gabbay, col. 1, ll. 5-7; col. 2, ll. 47-48; fig. 1.
Gabbay does not discuss the properties of Delrin thermobonded to
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a fabric, such as Dacron. Gabbay, passim.
9. McNeil discloses a plastic covered fastening device and a method
of assembling the same. McNeil, col. 1, ll. 7-9. A rigid retainer
pin is inserted in a relatively long piece of resilient tubing made of
a plastic type material such as Delrin. McNeil, col. 1, ll. 25-28;
col. 6, ll. 4-14; fig. 1. Then, while under sufficient tension to
reduce the external diameter of the tubing around the retainer pin,
the pin and tube combination is inserted through one or more
apertures such as in a support member. McNeil, col. 1, ll. 28-34;
figs. 2, 3. After insertion, the tension on the tubing is released,
permitting the tube and pin combination to expand and fix the
retainer pin in at least one of the apertures. McNeil, col. 1, ll. 35-
38. McNeil does not discuss the properties of Delrin
thermobonded to a fabric, such as Dacron. McNeil, passim.
ANALYSIS
Rejection of claims 11 and 12 under 35 U.S.C. § 102(b) as anticipated by
Love
Independent claim 11 is directed to an implant valve comprised of a
flexible tube and a hollow, substantially cylindrical support that extends over
a part of the length of the flexible tube. The support includes a casing that is
expandable in diameter from an initial position to an implantation position,
such that a first portion of the flexible tube clamps substantially coaxially
along the inner wall of the blood vessel, and a second portion of the flexible
tube provides a flexible, tubular valve body, that when in use, extends
substantially clear of the inner wall of the blood vessel.
We find that Love’s valve is not inherently expandable in diameter as
called for in claim 11. Love’s stents are comprised of Delrin thermobonded
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to a fabric covering so that the Delrin flows into the interstices of the fabric
(Fact 3). The references provided by the Examiner regarding the flexibility
of Delrin do not address the flexibility of Delrin thermobonded to a fabric
(Facts 7-9). Further, such a configuration, with the Dacron fabric embedded
in the Delrin stent, suggests a lack of flexibility. Additionally, the
Examiner’s finding that Love’s valve is necessarily expandable in diameter
because Delrin is flexible (Ans. 4) fails to account for the configuration and
composition of Love’s valve. For Love’s valve to expand in diameter, the
stents comprised of Delrin thermobonded to Dacron, as well as tissue
cylinder 13, would have to be expandable in diameter (Facts 1-5).
Further, while Delrin alone is a flexible material, Delrin’s flexibility
varies with thickness (Facts 7-9; App. Br. 7), and as mentioned supra, the
stents of Love’s valve are not comprised of Delrin alone, but rather are
Delrin thermobonded to a Dacron fabric (Fact 3). Love’s description of its
valve, in use, also weighs against finding that Love’s valve is inherently
expandable. In particular, Love discloses that its valve does not expand in
diameter to be installed, but rather is installed by sewing a flange on the
valve (flange 18) to the patient’s heart (Facts 1, 2; App. Br. 3, 7). Also,
Love discloses that the stents are produced in a variety of sizes to permit
selection of a size which best fits a patient (Fact 6). Given these facts, we
find that the Examiner has not sustained his burden of establishing that
Love’s valve is inherently expandable as called for in claim 11 to a
preponderance of the evidence. See In re Robertson, 169 F.3d 743, 745
(Fed. Cir. 1999) (citations and internal quotation marks omitted)
(“Inherency, however, may not be established by probabilities or
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possibilities. The mere fact that a certain thing may result from a given set
of circumstances is not sufficient.”).
The rejection of claim 12 is also in error by virtue of its dependence
from independent claim 11.
Rejection of claims 11 and 12 under 35 U.S.C. § 103(a) as unpatentable
over Love and either Black, or McNeil, or Gabbay
Given our analysis of the rejection of claim 11 as anticipated by Love,
supra, we fail to see, and the Examiner has failed to articulate, how the fact
that Delrin can be flexible would guide a person of ordinary skill to modify
Love’s valve to be expandable as claimed.
The proposed combination is not based upon a sufficient reason with a
rational underpinning to explain why a person of ordinary skill in the art
would have modified Love’s valve to reach the subject matter of claim 11.
Rejection of claim 17 under 35 U.S.C. § 103(a) as unpatentable over Love,
and either Black, or McNeil, or Gabbay, and Donlon
Claim 17 is directed to a method of implanting the valve of claim 11
that includes the steps of inserting the valve in a blood vessel in the initial
position, transporting the valve to the location of implantation, and bringing
the casing of the support to the implantation position so that a first part of
the tube clamps substantially coaxially along the inner wall of the blood
vessel and a second part of the tube provides a flexible, tubular valve body
that extends substantially clear of the inner wall of the blood vessel. Thus
claim 17, like claim 11, requires that the valve is expandable in diameter to
the implantation position.
We determined in our analysis of the rejection of claim 11, supra, that
the proposed combination of Love and Black, or Gabbay, or McNeil fails to
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meet this limitation. The Examiner does not find that Donlon corrects this
deficiency. Ans. 5, 7. We conclude the proposed combination does not
include a valve that can be brought from an initial to an implantation
position as required by claim 17.

DECISION
We REVERSE the Examiner’s decision to reject claims 11, 12, and
17.

REVERSED

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