Ex Parte Salahieh et al

Patent Trial and Appeal Board

Nov 25, 2013

10893131 (P.T.A.B. Nov. 25, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte AMR SALAHIEH, ULRICH R. HAUG, HANS F. VALENCIA,
ROBERT A. GESHLIDER, TOM SAUL, and
DWIGHT P. MOREJOHN1
__________

Appeal 2011-013626
Application 10/893,131
Technology Center 3700
__________

Before ERIC GRIMES, MELANIE L. McCOLLUM, and ERICA A.
FRANKLIN, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
replacement heart valve, which have been rejected for obviousness. We
have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

1 Appellants identify the Real Party in Interest as Sadra Medical, Inc.
(Appeal Br. 2).
Appeal 2011-013626
Application 10/893,131

2
STATEMENT OF THE CASE
The Specification discloses “an apparatus for endovascularly
replacing a patient’s native heart valve. The apparatus comprises an anchor
having an expandable braid and a replacement valve adapted to be secured
within the patient.” (Spec. 4, ¶ 11.) The Specification’s Figures 2A and 2C
are reproduced below:

Figure 2A shows the apparatus in a collapsed configuration for
delivery within a lumen (id. at 10, ¶ 45). Figure 2C shows the anchor and
valve in an expanded configuration (id.). “As shown in FIGS. 2A, 2B, and
2C, the strand sections of braid 31 slide with respect to each other as the
anchor expands and foreshortens” (id. (as amended Aug. 24, 2006)).
Appeal 2011-013626
Application 10/893,131

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Claims 1, 54, 57-59, and 66-68 are on appeal. Claim 1 is illustrative
and reads as follows:
1. Apparatus for replacing a native aortic valve, the apparatus
comprising:
a replacement heart valve comprising:
an anchor comprising an expandable braided material,
the braided material comprising a plurality of strand sections
that slide with respect to each other as the anchor expands, the
anchor being adapted to be endovascularly delivered and
secured at an anchor site within the native aortic valve; and
a replacement valve secured to the anchor.

Claim 68, the only other independent claim on appeal, differs from
claim 1 only in that its last clause recites a replacement valve supported by,
rather than secured to, the anchor.
DISCUSSION
The Examiner has rejected claims 1 and 66-68 under 35 U.S.C.
§ 102(e) as anticipated by Hojeibane2 (Answer 4). The Examiner has
rejected claims 54 and 57-59 under 35 U.S.C. § 103(a) as obvious based on
Hojeibane and Berreklouw3 (Answer 5). The same issue is dispositive with
respect to both rejections.
The Examiner finds that Hojeibane discloses the apparatus of claim 1,
including an anchor comprising components that “may be conventionally
braided” (id. at 4). The Examiner interprets the claim language requiring
“sliding” as an intended use limitation “which is inherently met by
conventionally braided structures” (id.).

2 Hojeibane et al., US 2005/0096735 A1, May 5, 2005
3 Berreklouw, U.S. 6,790,229, Sept. 14, 2004
Appeal 2011-013626
Application 10/893,131

4
Appellants argue that Hojeibane describes its frame as being either cut
from a solid tube or sheet of material, or from wires formed by techniques
such as braiding and then welded, so that the elements do not slide relative
to each other (Appeal Br. 4). Similarly, Appellants argue that Hojeibane
describes its anchor as being “‘formed from a lattice of interconnected
elements.’ . . . By stating that the elements are interconnected, Hojeibane is
making clear that the elements are fixed to one another and cannot slide
relative to one another.” (Id. at 5.)
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros., Inc. v. Union Oil Co., 814 F.2d 628, 631
(Fed. Cir. 1987). “A reference may anticipate inherently if a claim
limitation that is not expressly disclosed ‘is necessarily present, or inherent,
in the single anticipating reference.’. . . The inherent result must inevitably
result from the disclosed steps; ‘[i]nherency . . . may not be established by
probabilities or possibilities.’” In re Montgomery, 677 F.3d 1375, 1379-80
(Fed. Cir. 2012) (citations omitted).
We agree with Appellants that the Examiner has not provided
sufficient evidence to support a finding that the anchor disclosed by
Hojeibane includes “braided material comprising a plurality of strand
sections that slide with respect to each other,” as required by claim 1.
Hojeibane discloses a “prosthetic valve [that] comprises a radially
expandable structural frame . . . [that] includes an anchor structure”
(Hojeibane 1, ¶ 9). In one embodiment, “the prosthetic valve comprises a
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,
Appeal 2011-013626
Application 10/893,131

6
The Examiner does not point to an express disclosure in Hojeibane
that the strand sections of its anchor 104 slide with respect to each other,
even in the embodiment in which the structural frame 101 is formed from
wire using braiding. Rather, the Examiner finds that sliding is an “intended
use limitation[ ] . . . which is inherently met by conventionally braided
structures” (Answer 4).
To be inherent, however, the limitation that is not expressly described
must necessarily be present in the prior art product. Montgomery, 677 F.3d
at 1379-80. The Examiner bears the burden of providing evidence sufficient
to support a prima facie case of anticipation, In re Oetiker, 977 F.2d 1443,
1445 (Fed. Cir. 1992), which includes evidence showing that all of the
limitations of the claimed invention are present, expressly or inherently, in a
prior art reference. Verdegaal Bros., 814 F.2d at 631.
Here, the Examiner has not provided an evidentiary basis to support
the finding that the wires in Hojeibane’s apparatus would necessarily slide if
made by braiding. Hojeibane expressly describes its braided embodiment as
a closed-cell structure created by welding at specific locations (Hojeibane 4,
¶ 57). The reference also states that making the structural frame 101 from a
single tube or sheet of material eliminates “the need for welding,” (id. at 4,
¶ 59), which further suggests that welding is needed in the braided
embodiment. Finally, Hojeibane’s figures show that each of the
circumferential loops of distal anchor 104 is connected to the adjoining
loop(s), which would seem to preclude them from sliding relative to each
other. The figures are supported in this regard by Hojeibane’s disclosure
Appeal 2011-013626
Application 10/893,131

7
that “the distal stent anchor 104 comprises a plurality of bridge members
314 that connect adjacent hoops 306A through 306D” (Hojeibane 5, ¶ 67).
We conclude, therefore, that the Examiner has not provided an
adequate basis for finding that Hojeibane describes an apparatus that
includes “a plurality of strand sections that slide with respect to each other as
the anchor expands,” as required by claims 1 and 68. The rejection of
claims 1 and 66-68 as anticipated by Hojeibane is reversed. The rejection of
claims 54 and 57-59 as obvious based on Hojeibane and Berreklouw relies
on the same unsupported finding discussed above with respect to
anticipation (see Answer 6). We therefore reverse the rejection for
obviousness as well.
SUMMARY
We reverse both of the rejections on appeal.

REVERSED

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