Ex Parte Brister

Patent Trial and Appeal Board

Dec 10, 2012

10531822 (P.T.A.B. Dec. 10, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte MARK BRISTER
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Appeal 2012-000541
Application 10/531,822
Technology Center 3700
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Before DEMETRA J. MILLS, ERIC GRIMES, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a stent
with multiple discrete coating sections. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

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Application 10/531,822

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Statement of the Case
Background
“The stent with an intermittent coating of the present invention
provides a coating having a plurality of discrete coating sections disposed on
a stent, i.e., an intermittent coating. The individual coating sections can
contain different drugs or therapeutic agents” (Spec. 4 ¶ 0020).
The Claims
Claims 1, 3-6, and 8-25 are on appeal. Claim 6 is representative and
reads as follows:
6. A coated stent comprising:
a stent having a plurality of end-to-end cylindrical
stent segments, the axes of the plurality of cylindrical stent
segments lying along a longitudinal axis of the stent, the
stent having a first region continuous across at least one pair
of the longitudinally adjacent cylindrical stent segments and
a second region continuous across at least one pair of the
longitudinally adjacent cylindrical stent segments; and
a coating including a first coating section comprising
a first polymer and a second coating section comprising a
second polymer, the first polymer being different than the
second polymer;
wherein:
the first coating section is a single layer directly
adjacent to and completely covering the outer surface in the
first region of the longitudinally adjacent cylindrical stent
segments; and
the second coating section is another single layer
directly adjacent to and completely covering the outer
surface in the second region of the longitudinally adjacent
cylindrical stent segments; and
the first region and the second region are discrete, and
the first coating section and the second coating section are
discrete.
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The issue
The Examiner rejected claims 1, 3-6, and 8-25 under 35 U.S.C.
§ 103(a) as obvious over Castro1 and Ragheb2 (Ans. 4-9).
The Examiner finds that Castro teaches a stent where the “stent has a
plurality of end to end longitudinally adjacent cylindrical stent segments
(See Fig. 6a), the axis of the stent segments lying along a longitudinal axis.
The stent has a first discrete region and second discrete region continuous
over at least one pair of adjacent cylindrical segments” (Ans. 4). The
Examiner finds that Castro teaches
a first coating section comprising a first polymer including a
first therapeutic agent (10) and a second coating section
comprising a second polymer including a second therapeutic
agent (80), the first coating section completely covering the
outer surface of the stent segments in the first region and the
second coating section completely covering the outer surface
of the stent segments in the second region … the first
polymer being different from the second polymer.

(Ans. 4-5). The Examiner finds that Castro teaches that the “first and second
regions can form a striped, spotted or ring pattern” (Ans. 5).
The Examiner acknowledges that “Castro does not explicitly disclose
the first coating section is a single layer directly adjacent to and completely
covering the outer surface in the first region and the second coating section
is a single layer directly adjacent to and completely covering the outer
surface in the second region” (Ans. 6).

1 Castro et al., US 6,616,765 B1, issued Sep. 9, 2003.
2 Ragheb et al., US 5,873,904, issued Feb. 23, 1999.
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Application 10/531,822

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The Examiner finds that “Ragheb discloses a coated stent that
incorporates the concept of applying coatings in different patterns, including
applying the coatings in parallel lines, particularly where two or more
bioactive materials are applied to the same surface indicating a first coating
section being discrete from a second coating section” (Ans. 6). The
Examiner finds it obvious “to apply the teachings of Ragheb to incorporate
into Castro a pattern that includes distinct parallel lines for each material
such that each material is adjacent to the outer surface of the stent and each
coating section is discrete” (Ans. 6).
Appellant
asserts that the Castro patent fails to disclose a stent having
a first region and a second region continuous across a pair of
longitudinally adjacent cylindrical stent segments, the first
region and the second region being discrete; and a coating
having a first coating section and a second coating section,
the first coating section and the second coating section being
different polymers, the first coating section and the second
coating section being discrete.

(Reply Br. 5). Appellant contends that the “Castro patent discloses forming
a number of minute patterns along the strut, but fails to disclose anything
regarding a larger overall region or section” (Reply Br. 5).
Appellant contends that “the Ragheb patent also fails to disclose
macroscopic patterns as claimed. The combination of the Castro patent and
the Ragheb patent would not suggest the Appellant’s invention as claimed to
one skilled in the art” (Reply Br. 7). Appellant contends that “the Ragheb
patent is limited to the use of bioactive materials without polymers, and
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Application 10/531,822

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teaches the use of bioactive materials alone without any other material”
(Reply Br. 8).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Castro and Ragheb render
claim 6 obvious?
Findings of Fact
The following findings of fact (“FF”) are supported by a
preponderance of the evidence of record.
1. Castro teaches “coating material on the stent and a system for
moving the nozzle along a pattern of the scaffolding network of the stent
while maintaining the nozzle in close proximity to or in contact with the
stent to avoid any significant application of the coating material in the gaped
regions of the scaffolding network” (Castro, col. 3, ll. 1-6).
2. Figures 14A and 14B of Castro are reproduced below:

Castro teaches that “first composition 10 is deposited on prosthesis 12 as
shown in FIG. 14A. Second composition 80 is then deposited to at least
partially cover first composition 10 as depicted in FIG. 14B” (Castro, col.
18, ll. 36-39).
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3. Castro teaches that “[s]econd composition 80 may be deposited
to avoid contact with composition 10, as depicted in FIG. 13A. Second
composition 80 may also be deposited adjacent to composition 10, as
depicted in FIGS. 13B and 13C” (Castro, col. 18, ll. 2-5).
4. Figures 13B and 13C of Castro are reproduced below:

“FIGS. 13B and 13C illustrate examples of a strut having a coating pattern
in which a first coating makes contact with a second coating” (Castro, col. 5,
ll. 38-40).
5. Ragheb teaches that “the bioactive material may be posited on
the one surface of structure 12 in a specific geometric pattern” (Ragheb, col.
19, ll. 65-66).
6. Ragheb teaches that for “example, the tips or arms of a stent
may be free of bioactive material, or the bioactive material may be applied
in parallel lines, particularly where two or more bioactive materials are
applied to the same surface” (Ragheb, col. 19, l. 66 to col. 20, l. 3).

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7. Figure 2 of the Specification is reproduced below:

“FIG. 2 shows a stent having an intermittent coating made in accordance
with the present invention. The stent 150 comprises a number of segments
160. The pattern of the stent segments 160 can be W-shaped or can be a
more complex shape with the elements of one segment continuing into the
adjacent segment” (Spec. 6 ¶ 00026).
8. The Specification teaches that:
coating section within the radial region 164 is disposed on a
single stent segment. The coating sections within the radial
regions 166 and 168 cross several stent segments. The
coating section within the radial region 170 crosses the
region where two segments join. Different therapeutic
agents can be included in the coating section within each
discrete radial region, although the same therapeutic agents
can be included in some of the coating sections, if desired.
For example, a therapeutic agent could be provided at the
ends of the stent to assist in the healing of edge dissection. A
therapeutic agent such as taxol could be included in coating
sections within the end radial regions 162 and 172, and a
different therapeutic agent such as rapamycin included in
coating sections within the middle radial regions
164,166,168, and 170.

(Spec. 7 ¶ 00029).
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9. The Specification teaches that “[a]ny method producing
discrete coating sections can be used, so long as the coating sections
produced are substantially separate and the overlap between coating sections
is maintained at an acceptable level. Some overlap between coating sections
to facilitate manufacturing can be allowed without departing from the spirit
of the presently claimed invention” (Spec. 10 ¶ 00037).
Principles of Law
The Examiner has the initial burden of establishing a prima facie case
obviousness under 35 U.S.C. § 103. In re Oetiker, 977 F.2d 1443, 1445
(Fed. Cir. 1992).
“[R]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
Analysis
We agree with Appellant that “the Castro patent fails to disclose any
macroscopic pattern as claimed” (Reply Br. 6). We further agree that “the
Ragheb patent also fails to disclose macroscopic patterns as claimed” (Reply
Br. 7).
While both Castro and Ragheb teach coating of the stents, Castro’s
figures only show the coating of particular struts within the large three
dimensional stent (FF 1-4) while Ragheb also does not clearly show coating
of the entire stent or an entire cylindrical portion of a stent, as versus coating
of specific struts (FF 5-6). In the absence of evidence demonstrating coating
entire stent segments similar to that shown in Figure 2 of the Specification
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(FF 7), we are constrained to reverse this rejection for failing to provide a
reason to perform the coating required by the claims such as “the first
coating section is a single layer directly adjacent to and completely covering
the outer surface in the first region of the longitudinally adjacent cylindrical
stent segments” (Claim 6).
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Castro and Ragheb render claim 6 obvious.
SUMMARY
In summary, we reverse the rejection of claims 1, 3-6, and 8-25 under
35 U.S.C. § 103(a) as obvious over Castro and Ragheb.

REVERSED
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