Ex Parte Campbell

Board of Patent Appeals and Interferences

Mar 5, 2012

10966865 (B.P.A.I. Mar. 5, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte LOUIS A. CAMPBELL
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Appeal 2010-006074
Application 10/966,865
Technology Center 3700
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Before: JENNIFER D. BAHR, LINDA E. HORNER, and
WILLIAM V. SAINDON, Administrative Patent Judges.

BAHR, Administrative Patent Judge.

DECISION ON APPEAL

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STATEMENT OF THE CASE
Louis A. Campbell (Appellant) appeals under 35 U.S.C. § 134 from
the Examiner’s decision rejecting under 35 U.S.C. § 103(a) claims 1-5, 14,
15, and 18 as unpatentable over Sauter (US 2005/0222675 A1, pub. Oct. 6,
2005) and Possis (US 3,997,923, iss. Dec. 21, 1976), claim 19 as
unpatentable over Sauter, Possis, and Appellant’s Admitted Prior Art
(AAPA), and claim 20 as unpatentable over Sauter, Possis, and Bedard (US
4,506,394, iss. Mar. 26, 1985). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

THE INVENTION
The claims are directed to a method for coupling a prosthetic heart
valve with an artificial graft during a surgical procedure to replace a
defective heart valve and blood vessel section. Spec. 1, para. [01]. Claim 1,
reproduced below, is illustrative of the claimed subject matter.
1. A method of coupling an elongated vascular graft having a
graft sidewall extending between graft proximal and distal
ends with a prosthetic heart valve, the prosthetic heart valve
comprising an annular, resilient sewing ring disposed about
a valve body, for replacement of a section of blood vessel
and a native heart valve comprising:
fitting an annular exterior surface of the sewing ring of
the prosthetic heart valve within a vascular graft lumen to
dispose the vascular graft proximal end overlying the
annular exterior surface; and
clamping the graft proximal end against at least a portion
of the annular exterior surface without perforating the
vascular graft to couple the vascular graft with the prosthetic
heart valve during chronic implantation and to inhibit blood
leakage through the proximal end of an elongated vascular
graft.
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OPINION
Appellant does not present separate arguments for the patentability of
claims 3, 5, 14, 15, and 18 apart from independent claim 1. Thus, in
accordance with 37 C.F.R. § 41.37(c)(1)(vii)(2011), these claims stand or
fall with representative claim 1. Appellant presents separate arguments
directed to claims 2 and 4, and separately argues the rejections of claims 19
and 20.
Claims 1, 3, 5, 14, 15, and 18
The Examiner found that Sauter discloses the method of claim 1,
including clamping a vascular graft 140 against at least a portion of an
annular exterior surface of a prosthetic heart valve, with the exception that
Sauter does not disclose the annular exterior surface being located on the
sewing ring (sewing cuff 120). Ans. 3-4; see Sauter, figs. 1, 2; para. [0032]
(describing use of helical rings, such as springs, to retain the graft and
sewing cuff onto the valve body).
The Examiner relied on Possis as evidence that prosthetic heart valves
having sewing rings (fabric collar 112) comprising both an annular exterior
surface for engagement around the valve body and an outwardly directed
flange for the purpose of accommodating sutures were known in the art at
the time of Appellant’s invention. Ans. 4; see Possis, col. 6, ll. 3-6; fig. 11.
The Examiner reasoned that it would have been obvious to substitute
the sewing ring of Sauter, which, as illustrated in figures 1-9, appears to
comprise only an outwardly extending flange, with the well-known sewing
ring design of Possis, which includes both an annular exterior surface
surrounding the valve body and an outwardly directed flange. Id.
According to the Examiner, upon making this substitution, it would further
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have been obvious to fit the annular exterior surface of the sewing ring
within the graft lumen, thereby disposing the graft proximal end overlying
the annular exterior surface of the sewing ring. Id.
Appellant argues that neither Sauter nor Possis teaches fitting a
sewing ring, or suturing assembly, within a vascular graft lumen and
clamping the graft against an exterior surface of the sewing ring, as called
for in the claim and that, in fact, Sauter teaches away from such an
arrangement. App. Br. 11-12; Reply Br. 6. Thus, according to Appellant,
even if one were to substitute the sewing ring of Possis for that of Sauter, the
method of claim 1, particularly including steps of fitting an annular exterior
surface of the sewing ring within a vascular graft lumen to dispose the
vascular graft proximal end overlying the annular exterior surface and
clamping the graft proximal end against the annular exterior surface, would
not have been obvious. Reply Br. 6.
Accordingly, the issue joined in the appeal of the rejection of claim 1
is whether Sauter and Possis render obvious the method of claim 1,
including the steps of fitting an annular exterior surface of the sewing ring
within a vascular graft lumen to dispose the vascular graft proximal end
overlying the annular exterior surface and clamping the graft proximal end
against the annular exterior surface.
A conclusion of obviousness must be supported by explicit findings
and analysis establishing an apparent reason to combine the known elements
in the manner required in the claim at issue. KSR Int’l Co. v. Teleflex, Inc.,
550 U.S. 398, 418 (2007). However, “the analysis need not seek out precise
teachings directed to the specific subject matter of the challenged claim, for
a court can take account of the inferences and creative steps that a person of
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ordinary skill in the art would employ.” Id. Moreover, nonobviousness
cannot be established by attacking the references individually when the
rejection is predicated upon a combination of prior art disclosures. See In re
Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
In determining whether the subject matter of Appellant’s claim 1
would have been obvious, the pertinent inquiry is not whether either Sauter
or Possis individually teaches or suggests placement of the annular exterior
surface of the sewing ring within the vascular graft lumen. Rather, the issue
is whether the combined teachings of these references render obvious the
claimed subject matter.
The substitution of Sauter’s sewing cuff 120 with a well-known
suturing assembly such as the one disclosed by Possis, including both an
axially extending annular exterior portion and a radially outwardly directed
flange, as proposed by the Examiner, in the arrangement illustrated in
Sauter’s figure 1, is nothing more than the simple substitution of one known
element for another. See KSR, 550 U.S. at 417. Thus, the articulated reason
for the proposed substitution has rational underpinnings.
As for the location of the annular exterior surface of the substituted
sewing ring (fabric collar 112) relative to the vascular graft, it is apparent
that there are three alternatives, namely, (1) disposing the proximal end of
the vascular graft and the entirety of the sewing ring in axially offset
positions as illustrated in figure 1 of Sauter, (2) disposing the proximal end
of the vascular graft within the lumen of the sewing ring as illustrated in
figure 5 of Sauter, or (3) disposing the annular exterior portion of the sewing
ring (fabric collar) within the vascular graft lumen. In cases such as this,
“[w]hen there is a design need or market pressure to solve a problem and
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there are a finite number of identified, predictable solutions, a person of
ordinary skill has good reason to pursue the known options within his or her
technical grasp.” KSR, 550 U.S. at 421. The result of the selection of any of
those known options “is likely the product not of innovation but of ordinary
skill and common sense.” Id.
We do not agree with Appellant that Sauter’s discussion of a
drawback of previous devices having the graft attached to the sewing ring
(para. [0009]) teaches away from fitting the annular exterior surface of the
substituted sewing ring (fabric collar 112) within the vascular graft lumen to
dispose the vascular graft 140 proximal end over the annular exterior
surface. See App. Br. 12. Sauter describes a conventional combined
vascular graft/heart valve arrangement, and points out that a drawback of
such an arrangement is that it requires a smaller valve, thereby resulting in
restricted flow area. Sauter, para. [0009]. Sauter, however, does not
elaborate on the particular structure of the valve, sewing ring, or graft
attachment means of this conventional arrangement. Thus, it is not apparent
that modification of the inventive arrangements disclosed by Sauter to
accommodate a sewing ring comprising an annular exterior surface and an
outwardly directed flange, as taught by Possis, with the annular exterior
surface fitted within the vascular graft lumen necessarily would require a
smaller valve as in the conventional arrangement described by Sauter. “A
person of ordinary skill is also a person of ordinary creativity, not an
automaton.” KSR, 550 U.S. at 421. It is not evident, and Appellant has not
adequately explained, why a person of ordinary skill in the art would have
been incapable, using ordinary creativity, of, for example, modifying the
graft retaining member 150, such as by placing it on the exterior rather than
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the interior of the graft (compare figs. 1 and 5), to accommodate the
additional material of the annular exterior surface portion of the sewing ring
without having to reduce the blood flow annulus 112 of the valve.
Moreover, even assuming that placement of the annular exterior surface
portion of the sewing ring within the graft lumen would require use of a
valve having a reduced blood flow annulus, such a trade-off would not
necessarily render unobvious the proposed modification. See Winner Int'l
Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n.8 (Fed. Cir. 2000)] (“The fact
that the motivating benefit comes at the expense of another benefit, however,
should not nullify its use as a basis to modify the disclosure of one reference
with the teachings of another. Instead, the benefits, both lost and gained,
should be weighed against one another.”).
Therefore, the Examiner did not err in concluding that Sauter and
Possis render obvious the method of claim 1, including the steps of fitting an
annular exterior surface of the sewing ring within a vascular graft lumen to
dispose the vascular graft proximal end overlying the annular exterior
surface and clamping the graft proximal end against the annular exterior
surface. We sustain the rejection of claim 1 and of claims 3, 5, 14, 15, and
18, which fall with claim 1.
Claim 2
Appellant argues that because Sauter’s compression ring 150 does not
include a sewing ring within the compression ring 150, and compression
ring 150 is not forced against at least a portion of an annular exterior surface
of the sewing ring, the combination of references is missing the additional
features of claim 2. App. Br. 13. Appellant’s argument does not take into
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account the modification of Sauter proposed by the Examiner, and thus is
not convincing. We sustain the rejection of claim 2.
Claim 4
Appellant argues that because Sauter’s compression ring 150 does not
encircle or enclose the sewing cuff 120, the combination of references does
not teach or suggest all features of claim 4. App. Br. 13. Appellant’s
argument does not take into account the modification of Sauter proposed by
the Examiner, and thus is not convincing. We sustain the rejection of claim
4.
Claim 19
Appellant argues that “[t]he Examiner does not provide how the
Admitted Prior Art can remedy the shortcomings of Sauter and Possis with
regard to claim 1.” App. Br. 15-16. For the reasons discussed above, we do
not agree with Appellant with respect to the asserted shortcomings of Sauter
and Possis in rendering obvious the subject matter of claim 1.
Consequently, we do not find this argument convincing. We sustain the
rejection of claim 19.
Claim 20
Appellant’s argument contesting the rejection of claim 20 as
unpatentable over Sauter, Possis, and Bedard is premised on Appellant’s
position that Sauter and Possis do not render obvious the method of claim 1,
including the steps of fitting an annular exterior surface of the sewing ring
within a vascular graft lumen to dispose the vascular graft proximal end
overlying the annular exterior surface, and that Bedard does not remedy this
deficiency. App. Br. 16-17. As we disagree with Appellant with respect to
the asserted shortcomings of Sauter and Possis in rendering obvious the
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subject matter of claim 1, this argument is not convincing. We sustain the
rejection of claim 20.

DECISION
For the above reasons, the Examiner’s decision is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED

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