Ex Parte Ley et al

Board of Patent Appeals and Interferences

Jul 19, 2007

10131772 (B.P.A.I. Jul. 19, 2007)

The opinion in support of the decision being entered today is not binding
precedent of the Board.

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte TIMOTHY J. LEY, GRAIG L. KVEEN, and BURNS P. DORAN
__________

Appeal 2007-2026
Application 10/131,772
Technology Center 3700
__________

Decided: July 19, 2007
__________

Before ERIC GRIMES, LORA M. GREEN, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a stent.
The Examiner has rejected the claims as anticipated and obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.
BACKGROUND
“Stents are radially expandable endoprostheses which are typically
intravascular implants capable of being implanted transluminally and
enlarged radially after being introduced percutaneously. . . . They are used
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to reinforce body vessels and to prevent restenosis following angioplasty in
the vascular system” (Specification 1).
The Specification discloses stents that are configured to “limit recoil
and add resistance to compression . . . and provide[] increased side
branch access . . .” (id. at 1-2). For example, one embodiment “comprises a
metal tube as shown in the Figure 2 end view, such as Nitinol, or stainless
steel preferably, which has been etched or more preferably laser cut to [a]
configuration . . . made up of a series of generally triangular-like expansion
cell elements” (id. at 4).
DISCUSSION
1. CLAIMS
Claims 33-41 are pending and on appeal. Claims 33 and 37 are
representative and read as follows:
Claim 33. A stent comprised of at least one cell structure
selected from the group consisting of I shaped bonate cell
structures oriented at an oblique angle relative to the
longitudinal axis of the stent, multibonate cell structures
oriented at an oblique angle relative to the longitudinal axis of
the stent and combinations thereof.

Claim 37. A stent comprising a plurality of bonate cell
structures wherein the bonate cell structures are I shaped, abut
one another and are disposed at an oblique angle relative to the
longitudinal axis of the stent.

Thus, claim 33 is directed to a stent that has at least one cell structure
that is an I-shaped bonate structure, a multibonate structure, or a
combination of the two. The cells must be oriented at an oblique angle
relative to the longitudinal axis of the stent.
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The Specification states that “the term ‘bonate’ refers to a structure
which has relatively wide end portions joined by a connecting portion which
is, at least in part, relatively narrow. A bonate cell structure is illustrated
generally at 100 in Fig. 12” (Specification 6).
The Specification states (id.) that
The term ‘multibonate’, for the purposes of this
disclosure, refers to a structure which has three or more
relatively wide end portions each of which is joined to a
common portion via a relatively narrow connecting portion. . . .
One such multibonate cell structure is shown generally at 120
in Fig. 13.
Claim 37 is directed to a stent that has a plurality of I-shaped bonate
cell structures. The I-shaped cells must abut one another and be oriented at
an oblique angle relative to the longitudinal axis of the stent.

2. PRIOR ART
The Examiner relies on the following references:
Ehr US 6,033,433 Mar. 7 2000
(filed Apr. 25, 1997)
Fischell US 5,695,516 Dec. 9. 1997
Fischell US 5,697,971 Dec. 16, 1997
Savin US 4,950,227 Aug. 21, 1990

3. ANTICIPATION
Claims 37-39 stand rejected under 35 U.S.C. § 102(e) as anticipated
by Ehr (Answer 3-4), on the basis that “Ehr discloses a stent consisting
entirely of interconnected, I-shaped, bonate cell structures disposed at an
oblique angle relative to the longitudinal axis as seen in Fig. 16” (id. at 4).
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The Examiner reproduced Ehr’s Fig. 16 and darkened the cells he
interpreted to be “I-shaped, bonate cell structures” (id.).
Appellants argue that Figure 23 of the instant Specification provides
an example of a stent having I-shaped cells (Br. 5). In contrast, Appellants
argue, “the Examiner merely drew an ‘I’ in the cell structure and declared
that this meant that the cell structure is a bonate cell structure that is I-
shaped.” (Br. 7). Appellants argue that the cells indicated by the Examiner
are not I-shaped because they do not have relatively wide end portions that
extend from both sides of the relatively narrow portion (id.; Reply Br. 3).
The Examiner argues that it is reasonable to interpret the term
“I shaped” as encompassing structures “generally shaped like an I” because
the I-shaped structures in Appellants’ Figures 17, 21a, and 23 are not
perfectly I-shaped, having instead “thickness, curvature and a gradual
tapering thickness where the sections meet. [The] Examiner asserts that
since this broad interpretation has been applied to the instant invention, so to
can it be applied to the prior art” (Answer 7-8). The Examiner argues that
the Specification provides “no reference . . . to give guidance as to how to
interpret ‘I’-shaped” (id. at 8).
It is well settled that “claims in an application are to be given their
broadest reasonable interpretation consistent with the specification and that
claim language should be read in light of the specification as it would be
interpreted by one of ordinary skill in the art.” In re Sneed, 710 F.2d 1544,
1548, 218 USPQ 385, 388 (Fed. Cir. 1983) (citation omitted).
In the instant case, as pointed out by the Examiner (Answer 8), the
Specification does not define the term “I shaped.” As also pointed out by
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the Examiner (id.), the structures in Figure 23 are not perfect “I” shapes
because they have curvature and gradual tapering that join the wider ends to
the narrow middle. We therefore agree with the Examiner that it is
reasonable to interpret “I shaped” to encompass any structure that is
generally shaped like an “I.”
Appellants’ annotated version of Ehr’s Figure 16 is reproduced below:

The annotated figure shows an enlarged section of Ehr’s cell structure, with
three cells shaded and labeled “A”, “B”, and “C”. The figure shows that the
wider end portions of cell “A” extend away from both sides of the narrower
portion of the cell that connects the two ends. Moreover, cell “A” has the
general appearance of a capital letter “I.” Thus, Appellants’ arguments to
the contrary notwithstanding, we agree with the Examiner that at least cell
“A” has the general shape of an “I.”
“Absent claim language carrying a narrow meaning, the PTO should
only limit the claim based on the specification or prosecution history when
those sources expressly disclaim the broader definition.” In re Bigio, 381
F.3d 1320, 1325, 72 USPQ2d 1209, 1211 (Fed Cir. 2004). Thus, we also
agree with the Examiner that it would be improper to limit claim 37 only to
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stents having a structure that closely resemble those shown in Appellants’
Figure 23.
Because we agree that the Examiner’s interpretation of claim 37 is
reasonable, and because claim 37 does not have any language that
distinguishes the term “I shaped” from Ehr, we agree with the Examiner that
claim 37 encompasses the stent shown in Ehr’s Figure 16. Also, because the
corners of cell “A” all touch each other, all of those cells “abut one another,”
as recited in claim 37.
Appellants also argue that Ehr does not anticipate claim 39.
Appellants refer to their annotated version of Ehr’s Figure 16 (reproduced
above), and argue that structure “C” is not a bonate structure because it does
not have “a relatively wide end portion joined by a connection portion which
is, at least in part, relatively narrow” (Br. 8). Appellants argue that because
cell “C” is neither bonate nor I-shaped, Ehr does not anticipate claim 39
(id.).
To demonstrate that cell “C” has relatively wide portions joined by a
connecting portion that is at least in part relatively narrow, the Examiner
provides an annotated version of Ehr’s Figure 16 (Answer 9), reproduced
below:

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The figure shows an enlargement of the cell labeled “C” by Appellants, with
the Examiner’s notation of relatively wide and relatively narrow portions.
We agree with the Examiner that cell “C” is bonate. According to the
Specification a cell is bonate if it “has relatively wide end portions joined by
a connecting portion which is, at least in part, relatively narrow”
(Specification 6). As demonstrated by the Examiner’s annotated drawing
above, cell “C” meets this definition.
To summarize, we agree with the Examiner that at least cell “A” of
Ehr’s stent has the general shape of an “I” and is oriented at an oblique angle
to the longitudinal axis of the stent. Because every cell “A” contacts every
other cell “A,” we agree with the Examiner that every cell “A” abuts every
other cell “A.” We therefore agree with the Examiner that Ehr’s stent
anticipates claim 37. Moreover, because all of the cells of Ehr’s stent are
bonate and interconnected, we also agree with the Examiner that Ehr’s stent
anticipates claims 38 and 39. We therefore affirm the Examiner’s
anticipation rejection of claims 37-39.
4. OBVIOUSNESS -- CLAIMS 37-41
Claims 37-41 stand rejected under 35 U.S.C. § 103 as being obvious
over Fischell ‘516 and Savin (Answer 4-5).
The Examiner asserts that “Fischell [‘516] discloses a stent consisting
entirely of interconnected, I-shaped, bonate cell structures[, but] does not
disclose that the bonate structures are disposed at an oblique angle” (id. at
5). To meet this deficiency the Examiner cites Savin as disclosing a stent
that can be deployed using a tapered balloon, in a stepped fashion, or by
opening only one end, leaving the other end to act as a filter (id.)
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The Examiner reasons that “[b]y using a tapered balloon to deliver the
stent of Fischell, the cell structures will be disposed at an oblique angle
relative to the longitudinal axis. The cell structures will converge
longitudinally toward the distal (or proximal) end of the stent, as well as
converge radially inward toward the longitudinal axis” (id.). The Examiner
concludes that one of ordinary skill would have considered it obvious to
deliver the stent of Fischell ‘516 using Savin’s tapered balloon since “Savin
states that . . . using a tapered balloon to deliver a stent provides numerous
advantages because it can be used in various areas of the body and can also
fulfill several functions (i.e. a stent or a filter)” (id.).
Appellants argue that the references teach away from their
combination “because the stent delivery system of Savin uses a stent that
maintains or decreases its length upon expansion whereas the stent of
Fischell [‘516] increases its length upon expansion” (Br. 9). Appellants
argue that the deployment method of Savin, in which retaining sleeves are
pulled away from the ends of the stent as it is expanded by an inflating
balloon, demonstrates the desirability of using a stent that maintains or
decreases its length, rather than a stent that increases in length, like the one
disclosed in Fischell ‘516 (id. at 9-10; Reply Br. 4-6).
We are not persuaded by this argument. Recently addressing the issue
of obviousness, the United States Supreme Court noted that the analysis
under 35 U.S.C. § 103 “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 ordinary skill in the art
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would employ.” KSR Int'l v. Teleflex Inc., 127 S. Ct. 1727, 1741, 82 USPQ2d
1385, 1396 (2007).
Moreover, it is well settled that, “in a section 103 inquiry, ‘the fact
that a specific [embodiment] is taught to be preferred is not controlling,
since all disclosures of the prior art, including unpreferred embodiments,
must be considered.’” Merck & Co. v. Biocraft Laboratories Inc., 874 F.2d
804, 807, 10 USPQ2d 1843, 1846 (Fed. Cir. 1989) (quoting In re Lamberti,
545 F.2d 747, 750, 192 USPQ 278, 280 (CCPA 1976).) Thus, “[a]ll the
disclosures in a reference must be evaluated, including nonpreferred
embodiments, and a reference is not limited to the disclosure of specific
working examples.” In re Mills, 470 F.2d 649, 651, 176 USPQ 196, 198
(CCPA 1972) (citations omitted).
We note that Savin discloses that “[i]n preferred embodiments . . . the
stent is formed of knitted material and the length of the stent does not
significantly change when the stent is expanded . . .” (Savin, col. 2, ll. 20-
27). Rather than limiting its disclosure to stents that lengthen on
deployment, however, Fischell ‘516 actually states that “[a]t the nominal
fully-deployed diameter, the deployed stent is exactly the same length as the
non-deployed length. This characteristic provides better assurance of
completely covering a dilated stenosis as compared to a stent that shortens in
length when deployed . . .” (Fischell ‘516, col. 1, ll. 30-35, emphasis added).
Therefore, rather than teaching away from using the stents of Fischell
‘516, Savin’s preference for non-lengthening stents suggests that the tapered
balloon deployment method would be useful with the non-lengthening stent
embodiments of Fischell ‘516.
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We also note that Savin discloses that a stent that decreases in length
upon expansion “enhances its release from [the delivery] system” (Savin col.
5, ll. 48-49). However, Savin qualifies this preference in the next sentence,
stating that “[a]ny kind of stent may be delivered by this system, including
plastically deformable or elastically deformable stents” (id. at col. 5, ll. 49-
51, emphasis added). Therefore, because Savin’s disclosure is not limited to
stents that shorten upon deployment, we do not agree that Savin teaches
away from delivering the stents disclosed in Fischell ‘516 with the tapered
balloon delivery system.
Appellants argue that the stent of Fischell ‘516 has hour-glass shaped
cells, rather than the I-shaped cells required by claim 37 (Reply Br. 4).
We do not find this argument persuasive of nonobviousness. As
discussed above, we agree with the Examiner that, when given its broadest
reasonable interpretation in light of the Specification, the term “I shaped”
encompasses any structure that is generally shaped like an “I.” We note that
the cells of the stent of Fischell ‘516 could be characterized as hour glass-
shaped. However, because the cells have two wider end portions which
extend from both sides of a narrower connecting portion that extends along a
central axis (see Fischell ‘516, Figure 1), we agree with the Examiner that
the cells are also generally shaped like an “I.” We therefore also agree that
claim 37 encompasses the cells of the Fischell ‘516 stent.
To summarize, Appellants’ arguments do not persuade us that the
Examiner erred by concluding that claims 37-41 are obvious over the cited
references. We therefore affirm the Examiner’s obviousness rejections of
claims 37-41.
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4. OBVIOUSNESS -- CLAIMS 33-36
Claims 33-36 stand rejected under 35 U.S.C. § 103 as being obvious
over Fischell ‘971 and Savin (Answer 6-7).
The Examiner asserts that “Fischell discloses [a] stent with a plurality
of I-shaped bonate cell structure[s] and multibonate cell structures wherein
the cell structures are interlocking,” but that “Fischell does not disclose that
the structures are oriented at an oblique angle” (id. at 6). Citing Savin to
meet this deficiency, the Examiner again reasons that “[b]y using a tapered
balloon to deliver the stent of Fischell, the cell structures will be disposed at
an oblique angle relative to the longitudinal axis. The cell structures will
converge longitudinally toward the distal (or proximal) end of the stent, as
well as converge radially inward toward the longitudinal axis” (id. at 6-7).
The Examiner concludes that it would have been obvious to use Savin’s
tapered balloon to deploy the Fischell ‘971 stent because Savin discloses that
its delivery system is advantageous “because it can be used in various areas
of the body and can also fulfill several functions (i.e. a stent or a filter)” (id.
at 7).
Appellants argue that expanding only one end of the Fischell ‘971
stent to form a filter “would render the stent of Fischell [‘971] unsatisfactory
for its intended purpose, namely, to provide support to a main branch vessel
on either side of a bifurcation and to provide an opening to the side branch
vessel of the bifurcation” (Br. 13). Appellants argue that if only one end of
the Fischell ‘971 stent were expanded, the stent would not provide support to
the wall of the main branch vessel, because the special expandable cells
require positioning adjacent to the side branch ostium of a bifurcation (id.).
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Because forming a filter would render the Fischell ‘971 unsatisfactory for its
intended purpose, Appellants argue, “there is no suggestion or motivation to
make the proposed modification and the combination of Fischell [‘971] and
Savin does not teach or suggest instant independent claim 33” (id.).
Appellants also argue that “there would have been no need to look to
Savin in order to use the stent of Fischell [‘971] in other vessels in the
human body” because Fischell ‘971 had already disclosed that the stent was
amenable to deployment in other types of vessels (id. at 13-14).
The Examiner responds that “by combining the stent of Fischell ‘971
with the tapered delivery balloon of Savin, one could enhance the use of the
Fischell ‘971 stent by providing numerous advantages such as delivering the
stent to various areas of the body and also fulfilling several functions (i.e. a
stent or a filter)” (Answer 12). The Examiner argues that using the stent as a
filter “is just one reason for combination. The focus of the combination is
using a tapered or stepped balloon to deliver the stent to locations not
contemplated by a straight stent” (id. at 13).
We agree with the Examiner that one of ordinary skill would have
considered it obvious to use Savin’s delivery system to deploy the Fischell
‘971 stent. Fischell ‘971 discloses a stent having two types of cells,
allowing the stent to be deployed in a main artery that connects with a
branching artery (Fischell ‘971, col. 1, ll. 29-40). One of the cells is
configured such that, once the stent is placed in the main artery, the cells can
be “expanded at the ostium of a side branch artery to a comparatively large
diameter without breaking any of the struts of the stent cell. By this
technique unobstructed blood flow of the side branch can be provided” (id.
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at col. 1, ll. 35-40). Fischell ‘971 discloses that while the focus of the
disclosure is on placing the stent into arteries, the stent “could also be
applied to other types of vessels of the human body such as bronchial tubes
in the lung or the bile duct in the liver” (id. at col. 4, ll. 32-36).
Savin discloses a stent delivery method in which the “[b]alloon
catheter . . . may be either non-tapered in the stent-engaging region . . . , or
tapered or stepped, as desired. This system may be used to deliver stents to,
for example, coronary arteries, peripheral arteries (e.g., popliteal artery) and
visceral arteries, veins, and to the biliary tree, the urinary tract, and the
gastro-intestinal tract” (Savin, col. 6, ll. 27-34). As discussed above, Savin
states that “[a]ny kind of stent may be delivered by this system, including
plastically deformable or elastically deformable stents” (id. at col. 5, ll. 49-
51).
Thus, Fischell ‘971 discloses that the two-cell-type stent can be
suitably deployed to different vessels in the body, and Savin discloses that
its delivery system can be used to deploy stents to a wide variety of vessels.
Given the broad applicability of Savin’s delivery system to “any kind of
stent” (Savin, col. 5, ll. 49-51), we agree with the Examiner that one of
ordinary skill would have reasonably concluded that Savin’s delivery
methods were suitable for deploying the Fischell ‘971 stent. Therefore, even
assuming for argument’s sake that one of ordinary skill would have
considered the Fischell ‘971 stent unsuitable for use as a filter, one of
ordinary skill would still have considered it obvious to use Savin’s tapered
balloon delivery methods to deploy the Fischell ‘971 stent into a tapered
vessel.
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Appellants argue that “the allegedly I shaped bonate cell in Fischell
[‘971] consists of two triangles connected by a plus sign (+). This shape is
more similar to a bow-tie shape than an I shape” (Reply Br. 7). Appellants
argue that a comparison of Figure 2 of Fischell ‘971 with Figure 23 of the
instant Specification supports this argument (id.).
We do not find this argument persuasive. As discussed above, we
agree with the Examiner that the term “I shaped” can reasonably be
interpreted to encompass any structure that is generally shaped like an “I.”
It is true that the cells of the Fischell ‘971 stent can be characterized as
having a shape somewhat like a bow tie. However, because the cells have
two wider end portions which extend from both sides of a narrower
connecting portion that extends along a central axis we agree with the
Examiner that the cells are also generally shaped like an “I.”
Moreover, “[a]bsent claim language carrying a narrow meaning, the
PTO should only limit the claim based on the specification or prosecution
history when those sources expressly disclaim the broader definition.” In re
Bigio, 381 F.3d 1320, 1325, 72 USPQ2d 1209, 1211 (Fed Cir. 2004). Claim
33 does not contain any limitations on the structure of the I-shaped cells,
beyond the requirement that the cells be generally shaped like an “I.” The
Examiner therefore correctly interpreted claim 33 to encompass the Fischell
‘971 stent, rather than limiting claim 33 only to structures that closely
resemble the cells shown in Appellants’ Figure 23.
Appellants argue that neither Fischell ‘971 nor Savin discloses using
their stents at tapered or narrowing vessels and “there is no reasonable
expectation of success that the Fischell [‘971] stent can be used at a taper”
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(Reply Br. 7-8). Appellants argue that because the geometry of the Fischell
‘971 stent is consistent from end to end, deploying it in a tapered fashion
will result in one end of the stent covering a greater amount of vessel wall
than the other end (id. at 8). Thus, Appellants argue, “[i]t is not obvious that
it is desirable to cover a greater amount of the vessel wall or to have this
difference in vessel wall coverage. In addition it is not obvious that the
difference in vessel wall coverage would result in a successful outcome”
(id.).
We do not find this argument persuasive. As discussed supra,
Fischell ‘971 discloses that in addition to being useful when placed into
arteries, the stent “could also be applied to other types of vessels of the
human body such as bronchial tubes in the lung or the bile duct in the liver”
(Fischell ‘971, col. 4, ll. 32-36). Savin disclose that their stent delivery
system “may be used to deliver stents to, for example, coronary arteries,
peripheral arteries (e.g., popliteal artery) and visceral arteries, veins, and to
the biliary tree, the urinary tract, and the gastro-intestinal tract” (Savin, col.
6, ll. 27-34).
Given the variety of suitable locations and broad applicability for both
the Fischell ‘971 stent and the Savin delivery system, we agree with the
Examiner that one of ordinary skill would have reasonably expected that the
delivery system of Savin would be useful in deploying the Fischell ‘971
stent in a tapered configuration, resulting in a stent having I shaped bonate
cells oriented obliquely, relative to the longitudinal axis of the stent. We
therefore affirm the Examiner’s rejection of claims 33-36 over Fischell ‘971
and Savin.
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SUMMARY
We affirm the Examiner’s rejection of claims 37-39 as anticipated by
Ehr.
We affirm the Examiner’s obviousness rejection of claims 37-41 over
Fischell ‘516 and Savin.
We also affirm the Examiner’s obviousness rejection of claims 33-36
over Fischell ‘971 and Savin.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

Ssc

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