Ex Parte Boyle

Board of Patent Appeals and Interferences

Dec 22, 2008

10258087 (B.P.A.I. Dec. 22, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte CHRISTOPHER T. BOYLE
__________

Appeal 2008-1062
Application 10/258,087
Technology Center 3700
__________

Decided: December 22, 2008
__________

Before TONI R. SCHEINER, ERIC GRIMES, and LORA M. GREEN,
Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims directed to an endoluminal stent. The claims stand rejected as
anticipated. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
Appeal 2008-1062
Application 10/258,087

STATEMENT OF THE CASE
“[T]he present invention relates to an implantable medical device,
such as an endoluminal stent . . . having cavitated regions incorporated
within the material of the device with micropores that communicate a
bioactive agent from the cavity to an area external the device” (Spec. 1:
13-17).
Claims 5-10 and 15-21 are pending and on appeal. Claims 1-4 and
11-14 have been canceled.
Claims 5, 8, 15, and 19 are representative of the subject matter on
appeal:
5. An endoluminal stent, comprising:
a tubular member having a central lumen passing longitudinally
through the tubular member and open at opposing ends of the tubular
member, a luminal surface and an abluminal surface and a wall thickness
defined therebetween, at least one internal cavity residing within the wall
thickness in portions of the tubular member that are substantially isolated
from stress or strain forces on the endoluminal stent during delivery, a
plurality of openings communicating between the at least one internal cavity
and at least one of the luminal surface, abluminal surface, proximal end or
distal end of the tubular member, and at least one bioactive agent disposed in
the at least one internal cavity.

8. An endoluminal stent, comprising:
a cylindrical member comprised of a plurality of interconnected
structural elements defining walls of the cylindrical member, a plurality of
discontinuous interior cavities disposed completely within at least some of
the plurality of structural elements, and a plurality of openings
communicating between each of the plurality of discontinuous interior
cavities and external the stent, and at least one bioactive agent disposed
within the plurality of discontinuous interior cavities.

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15. An endoluminal stent for delivering a bioactive agent to a situs in a
body, comprising:
a plurality of struts interconnected at a plurality of hinge regions
forming a radially expandable cylindrical member, at least some of the
plurality of struts being further comprised of a first regions having a first
wall thickness and a second region having a second wall thickness, the first
region being in proximity to one of the plurality of hinge regions and the
second region being substantially isolated from each of the plurality of hinge
regions;
at least one void space formed entirely within the second wall
thickness of the second region, at least one of a plurality of pores
communicating between the at least one void space and through the second
wall thickness to at least one surface of the second region and external the
endoluminal stent, and at least one bioactive agent retained within the void
space and elutable through the at least one of a plurality of pores.

19. A drug eluting stent, comprising:
a plurality of metal strut members interconnected by a plurality of
hinge regions, each of the plurality of strut members having an intermediate
region between adjacent hinge regions, the intermediate region being subject
to relatively lower stress or strain forces than the hinge regions;
a metal covering layer disposed over at least some of the plurality of
strut members and covering the intermediate region of the strut members,
the covering layer having an inverted generally U-shape, such that the
covering layer and the intermediate region of each strut member defines an
internal cavity therebetween;
a plurality of openings formed in and passing through the covering
layer and communicating between the internal cavity and external the
covering layer;
and at least one bioactive agent disposed in the each internal cavity,
the at least one bioactive agent capable of being released from within the at
least one internal cavity through the at least one of a plurality of openings.

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The Examiner rejected the claims as follows:
1. Claims 5-10, 15, 16, and 19-21 under 35 U.S.C. § 102(e) as
anticipated by Brown (U.S. Patent 6,071,305, Jun. 6, 2000).
2. Claims 5-10 and 15-18 under 35 U.S.C. § 102(e) as anticipated by
Dang (U.S. Patent 6,758,859 B1, July 6, 2004).
3. Claims 5-10 and 15 under 35 U.S.C. § 102(e) as anticipated by Wu
(U.S. Patent 6,254,632 B1, July 3, 2001).
1. ANTICIPATION BY BROWN
Appellant argues the claims subject to this rejection in four groups as
follows: claims 5-7; claims 8-10; claims 15 and 16; and claims 19-21. We
select claims 5, 8, 15, and 19 as representative. 37 C.F.R. § 41.37(c)(1)(vii).
The Issue with Respect to Claims 5-7
Claim 5 is directed to an endoluminal stent comprising an open-ended
tubular member with a luminal surface and an abluminal surface, an internal
cavity within the tubular member containing a bioactive agent, and openings
communicating between the cavity and the luminal and/or abluminal
surfaces. There is no dispute that Brown discloses at least one embodiment,
a helical stent as shown in Figures 1, 2, and 3, that meets these particular
limitations of claim 5.
However, Appellant contends that the internal cavity of Brown’s
helical stent is not “substantially isolated from stress or strain forces on the
endoluminal stent during delivery,” as further required by claim 5 (App. Br.
10).
The Examiner’s position is that the internal cavity in Brown’s helical
stent is isolated from stress and strain during delivery of the stent because
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“no stress/strain is applied until expansion, which occurs after delivery”
(Ans. 10).
Thus, the issue raised by this rejection with respect to claim 5 is:
Has Appellant established that the Examiner erred in concluding that the
cavity in Brown’s helical endoluminal stent is substantially isolated from
stress and strain during delivery of the stent?
Findings of Fact
FF1 Appellant invented a “generally tubular” endoluminal stent
“having cavitated regions incorporated within the material of the . . . [stent]
with micropores that communicate a bioactive agent from the cavity to an
area external the device” (Spec. 1: 15-17 and 26).
FF2 Claim 5 requires a stent made up of a tubular member having a
central lumen where at least one internal cavity is located in a portion of the
tubular member that is substantially isolated from stress or strain during
delivery of the stent.
FF3 The Specification teaches that “all stents have certain structural
regions that are subject to higher stress and strain conditions than other
structural regions” because “stents necessarily are delivered in a reduced
diametric state and are expanded or allowed to expand in vivo to an enlarged
diametric state” so that they can serve as structural supports once in place
(Spec. 5: 6-9). In other words, stents are initially biased toward a reduced
state, and forced into an expanded state once in place, or they are initially
biased toward an expanded state, but forced into a reduced state for delivery,
and allowed to expand once in place.
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FF4 According to the Specification, “it may be advantageous to
position the internal cavities that retain the bioactive agents in structural
regions of the stent that are subjected to relatively lower stress and strain
during endoluminal delivery and deployment. Alternatively, where delivery
of a bolus of a bioactive agent is desired, internal cavities may be positioned
in regions that undergo large deformation during delivery and deployment
thereby forcing the bioactive agent out of the internal cavity under the
positive pressure exerted by the deformation” (Spec. 5: 9-15).
FF5 Further according to the Specification, internal cavities may
“reside within regions of the device . . . that are substantially non-load
bearing” (Spec. 12: 6-7). Alternatively, “regions . . . that are deformed or
that are load bearing may include . . . internal cavities within their wall
thickness and provide for elution of a bioactive agent retained within the
internal cavity positioned at the load bearing region under the influence of a
positive motivating pressure exerted on the bioactive agent by deformation
or load stress transferred by the device geometry to the internal cavity and to
the bioactive agent” (Spec. 12: 10-15).
FF6 The Specification does not explicitly identify regions that are
“substantially isolated from stress or strain forces on the endoluminal stent
during delivery” (as required by claim 5), but it can be inferred from the
passages quoted in FF4 and FF5 that regions of the stent that undergo “large
deformation” during delivery and deployment, and/or load bearing regions,
are subject to higher stress and strain conditions than other structural
regions, while regions that do not undergo “large deformation,” or are non-
load bearing, are regions that are subject to lower stress and strain.
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FF7 The Specification teaches that “hinge regions . . . are load
bearing regions of the stent” (Spec. 12: 8-9), thus, hinge regions are regions
that are subject to higher stress and strain during delivery and deployment.
FF8 An example of a stent with internal cavities located in regions
substantially isolated from stress and strain is depicted in Figure 11 of the
Specification, reproduced immediately below:

Figure 11 shows a portion of an expandable stent in which “the plurality of
hinge regions 54 are devoid of internal cavities 56 because they are load
bearing regions of the stent” (Spec. 12: 8-9).
FF9 Brown describes a drug delivery stent 11, an example of which
is illustrated in Figures 1 and 2, reproduced immediately below:

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Figure 1 is a perspective view of a stent 11 “formed from an elongated or
tubular member 12 . . . [which] is in the shape of a coil or helix, and is
expanded within a body lumen” after delivery (Brown, col. 5, ll. 39-42).
Figure 2 is a cross-sectional view of a body lumen and a perspective view of
stent 11 in place in the lumen (Brown, col. 3, ll. 63-65).
FF10 “The tubular or elongated member 12 of [Brown’s] directional
drug delivery stent 11 . . . is formed with an interior or cavity 20, which . . .
is a concave groove within the interior of the elongated member 12” (Brown,
col. 5, ll. 45-50). “[C]avity 20 contain[s] a biologically active agent for
directional application” (Brown, col. 4, ll. 62-63).
FF11 “Although the cavity 20 illustrated in [Brown’s] Fig. 2 is a
concave groove, the interior may be other configurations and need not
extend the entire length of the elongated or tubular member 12” (Brown, col.
5, ll. 51-54). In addition, “[a]lthough the slit shaped opening 22 is
illustrated, any number of fluid opening configurations may be fashioned.
For example, a series or plurality of holes, grooves, small indentations, and
intermittent recessions could all be fluid openings and delivery means for
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directionally delivering the biologically active agent” (Brown, col. 6, ll. 13-
17).
FF12 An embodiment of Brown’s helical stent with the cavity on the
luminal surface of the elongated, tubular member is shown in Figure 3,
reproduced immediately below:

Brown’s Figure 3 is a “cross-sectional view of the elongated member 12´ of
the stent 11´” (Brown, col. 8, ll. 5-6), in which cavity 20 and opening 22
extend along the luminal surface of elongated, tubular member 12´. That is,
both the cavity and the opening are on the inside surface of the stent.
FF13 Brown’s helical stent “has an initial diameter at which it is
inserted into a body lumen, and an expanded final diameter” once in place
(Brown, col. 7, ll. 26-28).
Analysis and Conclusion of Law, Claims 5-7
“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. of California, 814
F.2d 628, 631 (Fed. Cir. 1987).
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According to the Examiner, the cavity in Brown’s helical stent
“resid[es] within the wall thickness in portions of the tubular member that
are substantially isolated from stress or strain forces . . . during delivery”
(Ans. 4), at least in part because Brown’s stent is delivered in an un-
expanded state, and is subjected to minimal stress and strain until expansion,
“which occurs after delivery” (Ans. 10).
Appellant contends that “Brown discloses a helical coil stent structure,
where all the regions would undergo substantial stress and strain forces
during delivery and deployment . . . Consequently, Brown does not contain
the element recited in Claim 5 of an internal cavity substantially isolated
from stress or strain forces” (App. Br. 11).
Appellant’s argument is not persuasive. The Specification identifies
hinge regions as regions of relatively high stress and strain during delivery
and deployment (FF5, 6, 7). Brown’s helical stent has no hinge regions
(FF9). Nevertheless, even if we accept for the sake of argument that “all of
the regions” in Brown’s helical stent would undergo stress and strain at
some point during delivery and deployment, the Specification distinguishes
between delivery and deployment (FF3), and claim 5 merely requires
isolation from stress and strain during delivery (FF2). Brown’s stent is
delivered to a location in a vessel in an initial, unexpanded state, and is
expanded to its final diameter (i.e., deployed) after delivery (FF13).
Appellant has not established that Brown’s helical stent is either load-
bearing or deformed during delivery, as opposed to deployment (i.e.,
expansion). Therefore, Appellant has not shown that the Examiner erred in
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concluding that “minimal stress/strain” is placed on the cavity of Brown’s
stent during delivery (Ans. 10).
The Issue with Respect to Claims 8-10
Claim 8 is directed to an endoluminal stent comprising a cylindrical
member comprised of a plurality of interconnected structural elements
defining walls, with a plurality of discontinuous interior cavities disposed
within at least some of the structural elements.
The Examiner asserts that at least one of Brown’s embodiments, an
expandable “tube-type” stent as shown in Figure 18, meets all of the
limitations of claim 8, including the requirement for a plurality of
discontinuous interior cavities.
Appellant contends that “Brown does not disclose ‘a plurality of
discontinuous interior cavities disposed completely within at least some of
the plurality of structural elements’, as recited in Claim 8” (App. Br. 11).
Thus, the issue raised by this rejection with respect to claim 8 is:
Has Appellant established that the Examiner erred in concluding that the
cavities in Brown’s tube-type stent are discontinuous?
Additional Findings of Fact
FF14 Claim 8 is directed to an endoluminal stent comprising a
cylindrical member comprised of a plurality of interconnected structural
elements defining walls of the cylindrical member, with “a plurality of
discontinuous interior cavities disposed completely within at least some of
the plurality of structural elements,” a plurality of openings communicating
between each of the cavities and the outside of the stent, and at least one
bioactive agent disposed within the cavities.
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FF15 According to the Specification, “both the plurality of internal
cavities 12 and the plurality of pores [i.e., openings] 14 may be positioned to
be discontinuous and in different circumferential or different longitudinal
regions of the tubular body 20” (Spec. 7: 21-23). In addition, “[w]ithin a
single one of the plurality of interconnected structural elements 21, the
internal cavities 12 may be separated by a separation member 25, which
completely subtends the internal cavity 12, divid[ing] it into discrete
discontinuous internal cavities 12” (Spec. 7: 23-26).
FF16 Brown describes a number of stent configurations other than the
helical stent discussed above, such as “expandable tube stents, roving wire
stents, and wire mesh stents. Thus the elongated member 12 may be the
filaments or fibers which form a mesh stent” (Brown, col. 7, ll. 37-39).
FF17 Brown’s Figures 17 and 18 show an expandable tube-type stent
before and after expansion, respectively. Figures 17 and 18 are reproduced
immediately below:

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Figure 17 “illustrates an example of the aforementioned expandable tube-
type stent 111 . . . [Figure 18] illustrates the stent . . . in an expanded state”
(Brown, col. 11, ll. 63-64).
FF18 Brown’s “tube-type stent 111 is manufactured by cutting an
elongated tubular member into tubular sections” (Brown, col. 12, ll. 1-2).
Then, “[a] recessed active agent receiving . . . groove 120 is formed in the
exterior surface 104 of the tube 102. The groove 120 . . . is preferably a
continuous helical or coiling groove extending around the tube 102 . . . the
groove 120 need not be continuous” (Brown, col. 12, ll. 14-20). “Once the
. . . groove 120 has been filled with active agent 123 . . . a plurality of . . .
slots 108 are formed in the tube 102 . . . and extend completely through the
tubular member . . . wall thickness” (Brown, col. 12, ll. 61-67).
FF19 Brown teaches that “one function of the slots is to permit the
stent 111 to be expanded” (Brown, col. 13, ll. 9-10). “Because the preferred
slots 108 extend longitudinally along the tube 102 and the . . . groove 120
extends helically around the tubular member, the slots intersect the groove
to define a plurality of spaced apart groove portions 114, each containing
active agent” (Brown, col. 13, ll. 14-19 (emphasis added)). In other words,
“[w]hen the tube is expanded, the tubular material between the slots 108
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forms the angled fibers or elongated members 112, and the slots 108 form
the interstitial openings 110 . . . . At least some of the elongated members
112 contain groove portions 114 or cavities in which the active agent is
located” (Brown, col. 13, ll. 23-29).
FF20 Thus, Brown describes a stent with spaced apart, i.e.,
discontinuous, interior cavities.
Analysis and Conclusion of Law, Claims 8-10
Appellant contends that “Brown’s ‘plurality of cavities’ in Fig. 18
does not make them discontinuous. For Claim 8, a discontinuous cavity is a
single cavity marked by a break or interruption” (Reply Br. 9). Appellant
concedes that Brown “disclose[s] a number of cavities per filament,” but
contends that “‘Discontinuous’ modifies cavity, thereby making
‘discontinuous interior cavities’ requiring that the cavity itself . . . be
discontinuous, not the plurality of cavities to be discontinuous” (id.).
Appellant’s argument is not persuasive. According to the
Specification, the cavities may be “discontinuous” in two ways: (1) they are
“positioned to be discontinuous and in different circumferential or different
longitudinal regions of the tubular body” (FF15), or (2), “[w]ithin a single
one of the plurality of interconnected structural elements 21, the internal
cavities 12 may be separated by a separation member 25 . . . [dividing the
cavities] into discrete discontinuous internal cavities 12” (FF15).
Claim 8 is not limited to the second embodiment described in the
Specification where a single cavity is divided into discrete, discontinuous
portions (FF14). Claim 8 merely requires “a plurality of discontinuous
interior cavities disposed completely within at least some of the plurality of
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structural elements” (FF14). Brown describes spaced apart grooves (i.e.,
cavities) disposed within different regions of the stent (FF19, 20), thereby
meeting the requirement of claim 8 for discontinuous interior cavities.
Appellant has not established that the Examiner erred in concluding
that the cavities in Brown’s tube-type stent are discontinuous.
The Issue with Respect to Claims 15 and 16
Claim 15 is directed to a radially expandable, cylindrical endoluminal
stent comprising a plurality of struts interconnected at a plurality of hinge
regions. At least some of the struts are comprised of a first region “having a
first wall thickness” in proximity to one of the plurality of hinge regions, and
a second region “having a second wall thickness” substantially isolated from
each of the plurality of hinge regions, with at least one void space formed
entirely within the second wall thickness of the second region (claim 15).
Appellant contends that Brown only discloses stents with struts
comprising a single wall thickness, and that Brown does not disclose “‘a
second region being substantially isolated from each of the plurality of hinge
regions; [with] at least one void space formed entirely within the second
wall thickness of the second region’” (App. Br. 13), and therefore fails to
meet all the limitations of claim 15.
The Examiner asserts that claim 15 does not require the first and
second thicknesses to be “two different thicknesses” (Ans. 11), nor does the
claim “exclude . . . [void spaces] from being on the first region of the stent”
(id.).

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The issue raised by this rejection with respect to claim 15 is: Has the
Examiner established that Brown anticipates the invention of claim 15 based
on the broadest reasonable interpretation of the claim consistent with
Appellant’s Specification?
Additional Findings of Fact
FF21 The Examiner finds that Brown’s expandable “tube-type” stent,
shown in Figure 18, meets all the limitations of claims 15 and 16, including
the requirement for struts comprising first and second wall thicknesses, and
the requirement for at least one void space formed entirely within the second
wall thickness of the second region, where the second region is substantially
isolated from each of the hinge regions (Ans. 5).
FF22 Appellant’s claim 17, which depends from claim 15 and is not
subject to this rejection, stipulates that “the second wall thickness is greater
than the first wall thickness,” further limiting the first and second wall
thicknesses to two different wall thicknesses. Thus, claim 15 does not
require the first and second wall thicknesses to be two different wall
thicknesses.
FF23 According to Appellant’s Specification, cavities may be located
in both load bearing regions (e.g., hinge regions) and non-load bearing
regions (e.g., regions isolated from hinge regions), in order to achieve the
desired rate and timing of elution of the active agent(s) (Spec. 12: 18).
FF24 Claim 15 requires “at least one void space formed entirely
within the second wall thickness of the second region” which is
“substantially isolated from each of the plurality of hinge regions,” but the
claim uses the open transitional term “comprising,” and is therefore not
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limited to a stent with voids located exclusively in regions isolated from the
hinge regions.
FF25 The expandable tube-type stent shown in Brown’s Figures 17
and 18 (reproduced above) has “[a] recessed active agent receiving portion
or groove 120 . . . formed in the exterior surface of the tube 102” (Brown,
col. 12, ll. 14-15). “Once the recessed active agent receiving portion or
groove 120 has been filled with active agent 123 . . . a plurality of
perforations, slits, or slots 108 are formed in the exterior surface 104 of the
tube 102, and extend completely through the tubular member thickness”
(Brown, col. 12, ll. 61-67). Slots 108 “intersect the groove to define a
plurality of spaced apart groove portions 114, each containing the active
agent” (Brown, col. 13, ll. 17-19).
FF26 Figure 18 (reproduced above) shows several spaced apart
groove portions or recessed active agent receiving portions 114 that are
formed entirely within regions that are substantially isolated from the hinge
regions.
Analysis and Conclusion of Law, Claims 15 and 16
“[D]uring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the specification.” In re Hyatt, 211
F.3d 1367, 1372 (Fed. Cir. 2000).
[T]he PTO applies to the verbiage of the proposed claims the
broadest reasonable meaning of the words in their ordinary
usage as they would be understood by one of ordinary skill in
the art, taking into account whatever enlightenment by way of
definitions or otherwise that may be afforded by the written
description contained in the applicant’s specification.

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In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). However, the claims
are not to be confined to the embodiments found in the Specification, and it
is improper to import limitations from the Specification into the claims. In
re Trans Texas Holdings Corp., 498 F.3d 1290, 1299 (Fed. Cir. 2007).
Appellant contends that Brown does not disclose “two different wall
thicknesses” as required by claim 15 (App. Br. 13).
This argument is not persuasive. Claim 15 does not require that the
first and second wall thicknesses are different (as opposed to narrower
dependent claim 17, which does) (FF22).
Appellant contends that “Brown’s Fig. 18 . . . clearly shows groove
portions 114 [that] intersect with or are immediately adjacent to . . . hinge
regions of the stent struts 112 . . . Thus, it cannot be said that the groove
portions 114 are substantially isolated from each [and every] of the plurality
of hinge regions, as claimed” (App. Br. 13, 14).
This argument is not persuasive. Claim 15 merely requires “at least
one void space formed entirely within the second wall thickness of the
second region” which is “substantially isolated from each of the plurality of
hinge regions,” and the open language of the claim does not preclude voids
located in the hinge regions as well (FF24) Moreover, this interpretation of
the claim is consistent with the Specification, which teaches that cavities
(i.e. void spaces) may be located in both load bearing regions (e.g. hinge
regions), as well as non-load bearing regions, depending on the desired
elution profile (FF23).
Finally, Appellant argues that groove space 114 “is not a ‘void space
formed entirely within’ a second wall thickness . . . [because] the groove
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portions 114 open not only at their upper opening, but the end openings
defined in the stent struts become exposed to the exterior of the wall
thickness of elongated members 112 . . . [and] the open surface of the groove
123 changes as the stent is radially expanded” (App. Br. 14).
This argument is not persuasive. Brown’s grooves are located in the
walls of the struts. Appellant has not identified anything in the Specification
which supports his restrictive definition of “a void space entirely within” the
wall thickness.
The Examiner has established that Brown anticipates the stent of
claim 15, based on a reasonable interpretation of the claim consistent with
the Appellant’s Specification.
The Issue with Respect to Claims 19-21
Claim 19 is directed in part to a drug eluting stent comprising a
plurality of metal strut members interconnected by a plurality of hinge
regions. The claim requires a generally U-shaped metal covering layer with
a plurality of openings formed in it, disposed over the intermediate regions
between adjacent hinges of at least some of the struts, defining an internal
cavity therebetween.
The Examiner asserts that the requirement for a U-shaped metal
covering is met by “portion 19” of Brown’s drug eluting stent (Ans. 6).
Appellant contends, at least in part, that “portion 19 is a portion of the
circumference of the elongated member . . . [and] is not a layer as to
anticipate Claim 19’s metal covering layer” (App. Br. 16).
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The issue raised by this rejection with respect to claim 19 is: Has the
Examiner provided an adequate factual basis to support her conclusion that
Brown discloses a stent with a U-shaped metal covering?
Additional Findings of Fact
FF27 The Examiner asserts that the required U-shaped “metal
covering layer may be considered to be [the] top layer of the stent 19, . . . [as
shown in] fig. 4, 6 for example” (Ans. 6).
FF28 Brown’s Figure 4 is reproduced immediately below:

Figure 4 is a cross-sectional view of the elongated member 12" of a stent
11" which “directionally delivers the biologically active agent 23 from the
cavity 20 and through the slit opening 22, which is located at the support
portion 19 of the outer surface 16, such that the biologically active agent is
delivered to the body lumen wall 26” (Brown, col. 8, ll. 55-60).
FF29 Elongated member 12" can form the struts of a mesh stent
(FF21), however, support portion 19 is an integral part of elongated member
12", and is not a U-shaped metal layer covering portion of the elongated
member/strut 12".
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Analysis and conclusion of Law, Claims 19-21
The Patent Office has the initial duty of supplying the
factual basis for its rejection. It may not, because it may doubt
that the invention is patentable, resort to speculation, unfounded
assumptions or hindsight reconstruction to supply deficiencies
in its factual basis. To the extent the Patent Office rulings are
so supported, there is no basis for resolving doubts against their
correctness. Likewise, we may not resolve doubts in favor of
the Patent Office determination when there are deficiencies in
the record as to the necessary factual bases supporting its legal
conclusion . . .

In re Warner, 379 F.2d 1011, 1017 (CCPA 1967) (emphasis in original).
Warner concerned the factual basis of an obviousness rejection, but its
central premise is equally appropriate here.
Even if we accept, for the sake of argument, that Brown’s support
portion 19, which is an integral part of elongated member/strut 12" (FF29),
is a “covering layer” forming a cavity between the strut and support portion
19, the Examiner has not pointed to anything in Brown which shows that it
is U-shaped.
Thus, the Examiner has not provided the factual basis necessary to
support her conclusion that Brown discloses a stent with a U-shaped metal
covering.
Decision with Respect to Anticipation by Brown
We affirm the rejection of the claims under 35 U.S.C. § 102(e) as
anticipated by Brown with respect to claims 5-10, 15, and 16, but reverse the
rejection with respect to claims 19-21.

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2. ANTICIPATION BY DANG
The Examiner rejected claims 5-10 and 15-18 under 35 U.S.C.
§ 102(e) as anticipated by Dang.
The Issue
The Examiner’s position is that Dang describes an endoluminal stent
comprising a tubular member that meets all of the limitations of claims 5-10
and 15-18, including the requirement for “a plurality of openings
communicating between the at least one internal cavity and at least one of
the luminal surface, abluminal surface, proximal end or distal end of the
tubular member” (claim 5); the requirement for “a plurality of openings
communicating between each of the . . . interior cavities and external the
stent” (claim 8); and the requirement for “a plurality of pores
communicating between the at least one void space [formed entirely within
the wall of the stent] . . . and external the endoluminal stent” (claim 15).
Appellant contends in part that Dang does not teach or disclose a
“plurality of openings” or a “plurality of pores” communicating between
any single internal cavity or void space in the wall of the stent and the
exterior of the stent (App. Br. 21, 23), as required by all the claims subject to
this rejection. In other words, Appellant contends that Dang discloses only a
“single opening” per cavity or void space (id. at 21).
Thus, the issue raised by this rejection with respect to claims 5-10 and
15-18 is: Has the Examiner provided an adequate factual basis to support her
conclusion that Dang discloses a stent with a plurality of openings or pores
communicating between an internal cavity or void and the surface of the
stent?
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Findings of Fact
FF30 All of the claims subject to rejection over Dang require a
plurality of openings or pores communicating between a single internal
cavity or void, residing or disposed within the wall thickness or structural
elements of the stent, and the exterior of the stent. That is, all of the claims
require more than one opening or pore per cavity or void. Moreover, the
luminal surface of the stent is not a cavity or void residing or disposed
within a wall thickness or structural element of the stent.
FF31 Dang describes a cylindrical or tubular expandable “prosthesis,
one example of which includes a stent . . . The outer surface of the prosthesis
is capable of contacting an inner lumen surface of a passageway. In
addition, the body structure of the prosthesis has one or more elements
having a width and a thickness. The width of the element(s) is variable from
a nominal or conventional width to an increased width” (Dang, col. 2, ll. 41-
51).
FF32 Dang’s “variable width prosthesis includes one or more depots
formed on the elements of the prosthesis. The depots have an open end, a
closed end, a diameter and a depth that is less than the thickness of the body
structure of the prosthesis. In general, the depots are formed at the increased
width sections of the elements” (Dang, col. 2, ll. 52-58).
FF33 “The depots 30 are formed to carry . . . therapeutic substances”
(Dang, col. 5, ll. 10-11), and the depth, diameter, and quantity of the depots,
as well as their location on the elements 22 of the stent, varies according to
intended usage and application (Dang, col. 6, ll. 24-27; col. 8, ll. 29-30).
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FF 34 Dang’s Figures 5a and 5b, reproduced immediately below,
show cross-sectional and top views of “a plurality of depots on a surface
portion” of a stent (Dang, col. 3, ll. 20-23):

Figures 5a and 5b illustrate cross-sectional and top views of individual
depots 30 for therapeutic substances.
FF35 While Dang’s stent has a plurality of depots, and “depot
configurations . . . can include . . . tear-drop shaped, cubic shaped,
spherically shaped, and other configurations and shapes” (Dang, col. 6, ll.
60-63), none of the depots described by Dang has more than one opening per
depot.
Analysis and Conclusion of Law
All of the claims subject to this rejection require a plurality of
openings or pores per cavity or void (FF30), not merely a plurality of
openings or pores in the stent as a whole.
The Examiner asserts that Dang describes a stent with “a plurality of
openings (open end is considered an ‘opening’ . . . [and] the cavities may be
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any shape, including shapes such as tear drop, wherein the opening is
smaller that the cavity . . . ) communicating between the at least one internal
cavity (30) and at least one of the luminal surface, abluminal surface,
proximal end, or distal end of the tubular member (fig. 5a)” (Ans. 7).
We agree with Appellant that “no single depot 30 disclosed in the
Dang reference contains a ‘plurality of openings’, i.e., more than one
opening . . . [and] [a] tear drop opening still only contains a single opening”
(App. Br. 21).
Thus, the Examiner has not provided an adequate factual basis to
support her conclusion that Dang discloses a stent with a plurality of
openings or pores communicating between an internal cavity or void and an
exterior surface of the stent.
Decision
We reverse the rejection of claims 5-10 and 15-18 under 35 U.S.C. §
102(e) as anticipated by Dang.
3. ANTICIPATION BY WU
The Examiner rejected claims 5-10 and 15 under 35 U.S.C. § 102(e)
as anticipated by Wu.
The Issues
Appellant contends, among other things, that “Wu does not disclose ‘a
plurality of openings communicating between the at least one internal cavity
and at least one of the luminal surface’” as required by claims 5-7 (App. Br.
27), or “a plurality of discontinuous interior cavities disposed completely
within at least some of the plurality of structural elements” (id. at 28) with “a
plurality of openings communicating with an internal cavity and external the
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stent” as required by claims 8-10 (id. at 29); or “a ‘void space formed
entirely within the second wall thickness’ of a strut region” as required by
claim 15 (id.).
The Examiner’s position is that “Wu discloses a stent . . . comprising
a structural member (104, 102) and cover member (420) and a cavity (area
occupied by agent 410 . . . ) therebetween, and a plurality of openings
(openings in porous polymer cover 420) passing through the cover member”
(Ans. 9).
The issues raised by this rejection are: Has the Examiner provided an
adequate factual basis to support her conclusion that Wu discloses a stent
with a plurality of openings or pores communicating between an internal
cavity and the surface of the stent, and that Wu describes a stent with
cavities or void spaces formed entirely within the structural elements or
struts of the stent, with a plurality of openings communicating between the
cavities or void spaces and the exterior of the stent?
Additional Findings of Fact
FF36 Wu describes “protruding structures . . . [on] the surface of a
stent . . . [which] can be used with covered stents . . . to engage and secure
the cover, . . . to keep glue in place on the stent when attaching the covering.
The protruding structures can also be used to deliver therapeutic substances
from the stent directly to the lumen wall” (Wu, col. 2, ll. 53-62).
FF37 “An exemplary protruding structure includes a depression
region having a bottom surface that is fully or partially surrounded by a
protruding lip . . . [that] is higher than the bottom surface relative to the
surface of the stent” (Wu, col. 2, l. 64 to col. 3, l. 2).
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FF38 Wu’s Figure 2B is reproduced immediately below:

Figure 2B “is a cross-sectional side view of a portion of a stent strut with a
crater that has a bottom surface recessed beneath the stent surface” (Wu, col.
3, ll. 46-48).
FF39 Wu’s Figure 4A is reproduced immediately below:

Figure 4A is a cross-sectional side view of a “protruding structure[ ] that
contain[s] a therapeutic substance . . . covered by a polymeric layer” (Wu,
col. 3, ll. 63-65).
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FF40 The Examiner describes polymeric layer 420 as “porous” (Ans.
9), but does not point to anything in Wu which indicates that the polymer
actually is porous. Wu merely describes the “[p]olymeric materials that can
be used for layer 420, 430 . . . [as] either bioabsorbable or biostable”
polymers which “are gradually absorbed or eliminated from the body by
hydrolysis, metabolic process, bulk or surface erosion” (Wu, col. 6, ll. 37-
43).
FF41 The Examiner’s assertion that Wu’s polymer layer 420 meets
the claims’ requirement for a plurality of openings per cavity or void space
is not supported by Wu’s description of the polymer layer.
Analysis and Conclusion of Law
While Wu’s stent has a plurality of cratered structures, the structures,
including the craters, protrude at least partially from the surface of the stent
(FF 36-39), thus none of the craters (i.e., cavities or voids) is “disposed
completely within” or “formed entirely within” a structural element or strut
(as required by claims 8-10 and 15). Moreover, none of the protruding
structures has more than one opening per crater (as required by claims 5-10
and 15) (FF40, 41).
The Examiner has not provided an adequate factual basis to support
her conclusion that Wu discloses a stent with a plurality of openings or pores
communicating between an internal cavity and the surface of the stent as
required by claims 5-7, or that Wu describes a stent with cavities or void
spaces formed entirely within the structural elements or struts of the stent (as
required by claims 8-10 and 15), with a plurality of openings communicating
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between the cavities or void spaces and the exterior of the stent (as required
by claims 5-10 and 15).
Decision
We reverse the rejection of claims 5-10 and 15 under 35 U.S.C.
§ 102(e) as anticipated by Wu.
SUMMARY
The rejection of claims 5-10, 15, 16, and 19-21 under 35 U.S.C. §
102(e) as anticipated by Brown is AFFIRMED with respect to claims 5-10,
15, and 16, but REVERSED with respect to claims 19-21.
The rejection of claims 5-10 and 15-18 under 35 U.S.C. § 102(e) as
anticipated by Dang is REVERSED.
The rejection of claims 5-10 and 15 under 35 U.S.C. § 102(e) as
anticipated by Wu is REVERSED.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006).

AFFIRMED-IN-PART

Ssc:

David G. Rosenbaum
Rosenbaum & Associates, P.C.
Suite #380
650 Dundee Road
Northbrook, IL 60062
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