Ex Parte DesNoyer et al

Board of Patent Appeals and Interferences

May 20, 2011

10750312 (B.P.A.I. May. 20, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte JESSICA R. DESNOYER and STEPHEN D. PACETTI
____________

Appeal 2009-009565
Application 10/750,312
Technology Center 1700
____________

Before PETER F. KRATZ, JEFFREY T. SMITH, and
MICHAEL P. COLAIANNI, Administrative Patent Judges.

KRATZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on an appeal under 35 U.S.C. § 134 from the
Examiner’s final rejection of claims 1, 4-9, 11, 13, 14, and 19-25. We have
jurisdiction pursuant to 35 U.S.C. § 6.

Appeal 2009-009565
Application 10/750,312

2

Appellants’ claimed invention is directed to a stent and a stent
mandrel supporting the stent. As reported by Appellants, a common
treatment for blood vessel occlusions involves the use/insertion of one or
more stents, which act as scaffoldings to physically hold open the affected
vessels (Spec. 1). Appellants illustrate a conventional stent 10 that includes
a plurality of radially expandable struts 12 in drawing Figure 1.
Appellants explain that a stent can be additionally used as a vehicle
for providing biological therapy via the application of a coating that includes
a medication to the stent (Spec. 1 and 2). For therapeutic purposes, drugs
need only be released from the abluminal stent surfaces, and possibly stent
sidewalls, according to Appellants. However, Appellants observe that the
application of a medicament to a stent, usually with a polymer and solvent,
via prior art spray application or dipping techniques, also provides the
luminal surfaces of the stent with unnecessary coating (Spec. 2). Aside from
the obvious waste, this result is said to be detrimental to the delivery of the
stent to the desired interior vessel location and the mechanical integrity of
the coating (Spec. 2-3).
Appellants’ mandrel for holding the stent and the stent reportedly
allows for the application of a therapeutic coating to the stent in a manner
that avoids or significantly reduces the deposit of the coating in a
detrimental amount and way to a stent luminal surface (Spec. 3 and 4, App.
Br. 2-5).
Claims 1, 9, and 23 are illustrative and reproduced below:
1. A stent and a stent mandrel support supporting the
stent, the stent comprising a plurality of struts, the support
comprising:
Appeal 2009-009565
Application 10/750,312

3
a first member to contact a first end of the stent;

a second member to contact a second end of the stent;
and

a third member connecting the first member to the second
member and extending through a longitudinal bore of the stent,
the third member shaped and/or sized to eliminate or
substantially prevent a coating from being formed on a luminal
surface of the stent during application of a coating substance to
the stent.

9. A stent and a mandrel supporting the stent, the stent
comprising a plurality of struts having abluminal surfaces and
luminal surfaces in fluid communication through at least a pair
of the plurality of struts, the mandrel comprising: a member to
penetrate at least partially into a longitudinal bore of the stent
during the application of a coating substance to the stent, the
member including outward projecting walls, the length of at
least one of the walls being not less than 25% of the length of
the stent.

23. A stent and a mandrel supporting the stent, the stent
comprising a plurality of struts having abluminal surfaces and
luminal surfaces in fluid communication through at least a pair
of the plurality of struts, the mandrel comprising: a member
penetrating at least partially into a longitudinal bore of the stent
during the application of a coating substance to the stent, the
member including outwardly projecting walls disposed around
the circumference of the mandrel, wherein each of the walls
converge with its neighboring wall at an angle.

In addition to the relied on admitted prior art teachings advanced by
the Examiner, the Examiner further relies on the following prior art
references as evidence in rejecting the appealed claims:
Rosenbluth 4,762,128 Aug. 9, 1988
Hattler 4,846,791 Jul. 11, 1989
Appeal 2009-009565
Application 10/750,312

4
Tower 5,389,106 Feb. 14, 1995
Berg 5,674,208 Oct. 7, 1997

The Examiner maintains the following grounds of rejection:
Claims 1 and 4-8 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Hattler in view of Berg. Claims 1 and 4-8 stand rejected
under 35 U.S.C. § 103(a) as being unpatentable over Hattler in view of
Tower. Claims 9, 11, 13, 14, and 19-25 stand rejected under 35 U.S.C. §
103(a) as being unpatentable over Hattler in view of Rosenbluth and alleged
admitted prior art.
We reverse the above-identified rejections.1 Our reasoning follows.
All of the appealed claims are drawn to a stent and a mandrel for
supporting the stent.
Hattler is directed to a multi-lumen catheter. Hattler forms a plurality
of lumens by inserting a divider 30 into an expandable tube catheter 10
(Figs. 1, 7 and 8). This is done after a hollow needle 20, through or over
which the catheter was introduced into a blood vessel, is withdrawn from the
blood vessel (col. 4, l. 4- col. 5, l.15; col. 6, l. 27-52; Figs. 4-6). The
expandable tube catheter of Hattler is made of expandable material, such as
latex, vinyl, or silicon rubber and the divider is made from a material having
anti-friction properties, such as Teflon or nylon (col. 4, ll. 20-22; col. 5, ll.
16-24).
Berg is drawn to an intravascular flexible catheter that includes a
metallic braided wire support member located between inner and outer
tubular members.

1 No other grounds of rejection are before us for review.
Appeal 2009-009565
Application 10/750,312

5
Tower is directed to an expandable intravascular stent comprising a
distensible frame useful for supporting the wall of a blood vessel. Tower
discloses that a stent 10 can be carried on a mandrel 12 during manufacture
of the stent and that a synthetic polymer membrane 28 can be bonded to the
formed wire sleeve 11 by a dipping process resulting in the polymer
membrane spanning the interstices of the formed stent (col. 3, l. 23 - col. 4, l.
35). The stent is removed from the mandrel after formation. An inflatable
balloon catheter 30 is disclosed by Tower for placing the formed stent in a
blood vessel (col. 4, ll. 36-68; Figs. 2 and 3).
Rosenbluth is directed to an apparatus for treating hypertrophy of the
prostate gland. The apparatus includes an expansible catheter that can carry
an expansible tubular stent for transurethral insertion and placement of the
stent within a stenotic region of a urethral lumen caused by a hypertrophied
prostate gland (abstract).

ISSUES
Has the Examiner furnished a plausible rationale/reason to modify any
identified features of the multi-lumen catheter of Hattler with any identified
features of Berg, Tower, or Rosenbluth and the admitted prior art in a
manner so as to result in a stent and mandrel support for the stent as called
for in any of the rejected claims?
We answer in the negative for reasons argued by Appellants in the
Appeal Brief and the Reply Brief.
Concerning each of the first two obviousness rejections over claims 1
and 4-8, the Examiner correctly acknowledges that Hattler does not
explicitly disclose a stent comprising a plurality of struts, as required by
Appeal 2009-009565
Application 10/750,312

6
claim 1. In considering Hattler, the Examiner seems to have overlooked or
misapprehended the relevance of Hattler to the claimed subject matter
because the Examiner has not presented a reasonable explanation as to how
Hattler discloses or suggests a stent, even without struts, and/or a mandrel
for support of a stent, as recited in claim 1, by referencing the catheter
depicted in Figures 1-3 of Hattler (Ans. 3-7). This is made apparent by a
reading of Hattler and Appellants’ reasonable descriptions of Hattler and the
claimed stent and mandrel, as set forth in the Appeal Brief (App. Br. 2, 3, 6-
8, 13-16).
Regarding the first obviousness rejection, the Examiner turns to Berg
for an alleged disclosure of a stent comprising a plurality of struts.
However, the Examiner has not proffered a rational basis for modifying the
multi-lumen catheter of Hattler in manner to result in a stent and mandrel
combination as recited in claim 1.
In this regard, Hattler is concerned with the formation of a multi-
lumen catheter tube by using a divider with larger outside dimensions than
the tube. The divider is inserted into the flexible tube after the tube has been
inserted into a blood vessel (Hattler, Figs. 1 and 4-8). As explained by
Appellants (App. Br. 13), the flexible catheter tube 10 radially expands
inside a blood vessel as the divider 30 is put in place to form multiple
lumens inside the tube. Hattler is not directed to a stent or a mandrel for
supporting a stent, as one of ordinary skill in the art would understand. Berg
is likewise directed to a catheter, not a stent or a stent support mandrel.
Thus, the Examiner’s conclusory comments do not explain why one of
ordinary skill in the art would have been led to somehow modify the flexible
tube 10 of Hattler by employing the wire braid of Berg to stiffen the tube of
Appeal 2009-009565
Application 10/750,312

7
Hattler in manner so as to result in the formation of a stent with struts, and a
mandrel support as claimed from a modification of the multi-lumen tube of
Hattler (Reply Br. 1).
Turning to the second obviousness rejection of claims 1 and 4-8 over
Hattler and Tower, the Examiner has similarly failed to present a reasoned
basis for a particular modification of Hattler’s catheter that would result in a
stent supported on a mandrel, as required by claim 1, based on any
particularly identified teachings of Tower. In this regard, we are cognizant
that Tower discloses an intravascular stent and mandrel combination (Fig.
1).
Tower’s mandrel structure is used, at least in part, for forming a stent
and providing the stent with a synthetic polymer membrane 28 that can be
bonded to a stent wire sleeve 11 by a dipping process. This apparatus allows
for the polymer membrane to span the interstices of the formed stent (Fig. 1;
col. 3, l. 23 - col. 4, l. 35). However, the Examiner does not predicate the
stated rejection on a proposed modification of the Figure 1 stent and mandrel
combination of Tower. Rather, and like in the first stated rejection, the
Examiner proffers an obviousness rejection based on a modification of the
catheter of Hattler. In this instance, the proposed modification is apparently
based on the dissimilar balloon catheter stent delivery system and stent of
Tower (Ans. 6; Tower, Figs. 2-7). Here, again, the Examiner has not
proffered a rational basis for converting, in some way, the multi-lumen
catheter of Hattler into a stent and mandrel support based on the balloon
delivery system for a stent taught by Tower.
The Examiner’s obviousness rejection of claims 9, 11, 13-14, and 19-
25 over Hattler in view of Rosenbluth and admitted prior art is similarly
Appeal 2009-009565
Application 10/750,312

8
flawed as it is based on the Examiner’s misreading of the catheter divider 30
of Figures 12 and 13 of Hattler as a mandrel together with the catheter tube
10 as somehow correlating with a mandrel assembly. In this regard, the
Examiner has not presented a reasoned basis for modifying the multi-lumen
catheter structure of Hattler to form a stent and mandrel support as claimed
based on the expansible inflation catheter carrying an expansible tubular
stent for transurethral insertion and placement of the stent within a stenotic
region of a urethral lumen as taught by Rosenbluth and based on the
admittedly old stent having a plurality of struts of Appellants’ Figure 1.
Rosenbluth coats a stent and balloon catheter with a lubricant prior to
positioning the stent within the prostatic urethra as pointed out by the
Examiner (Ans. 8). However, this disclosure does not furnish any
reasonable impetus for one of ordinary skill in the art to convert the
dissimilar multi-lumen catheter of Hattler into a stent and a mandrel support
combination as Appellants’ claim, as basically argued by Appellants (App.
Br. 9-12; Reply Br. 2-4).

CONCLUSION
On this record, the Examiner has not furnished a reasoned basis for
the proposed modifications of Hattler based on the several secondary
references applied in the maintained obviousness rejections.

ORDER
The Examiner’s decision to reject the appealed claims is reversed.

REVERSED

Appeal 2009-009565
Application 10/750,312

9

kmm