Ex Parte Kloke et al

Board of Patent Appeals and Interferences

Jul 19, 2010

11156245 (B.P.A.I. Jul. 19, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/156,245 06/17/2005 Tim M. Kloke 01001.0031USU1 3652
78185 7590 07/20/2010
Pauly, Devries Smith & Deffner, L.L.C.
Plaza VII
45 South Seventh Street, Suite 3000
Minneapolis, MN 55402-1630
EXAMINER
KLINKEL, KORTNEY L
ART UNIT PAPER NUMBER
1611
MAIL DATE DELIVERY MODE
07/20/2010 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
_________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
_________________

Ex parte TIM M. KLOKE and RALPH A. CHAPPA

Appellants
_________________

Appeal 2010-004935
Application 11/156,245
Technology Center 1600
_________________

Before SALLY GARDNER LANE, RICHARD E. SCHAFER, and
MICHAEL P. TIERNEY, Administrative Patent Judges.

LANE, Administrative Patent Judge.

DECISION ON APPEAL1
I. STATEMENT OF THE CASE
The appeal, under 35 U.S.C. § 134(a), is from a Final Rejection of
Appellants’ claims 1, 2, 4, 5, 8-10, and 12. Appellants cancelled claims 3,

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode shown on the PTOL-90A cover letter attached to this decision.

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7, and 11, and withdrew claims 6 and 13-23. (App. Br. 5). We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.
Appellant’s specification is directed to coating systems for medical
devices to control release of therapeutic, active agents. (Spec. p. 1, ll. 9-11).
According to Appellants’ specification, the interaction of some coatings with
an active agent produces free radicals that are detrimental to the active agent.
(Spec. p. 2, ll. 8-10). Appellants’ device is said to avoid this problem by
adding a separating layer between the active agent and the coating polymer.
(Spec. p. 4, ll. 9-16).
The real party-in-interest is said to be SurModics, Inc. (App. Br. 3).
The Examiner relied on the following patent documents:
Roorda 2001/0007083 July 5, 2001
Sirhan 2003/0083646 May 1, 2003

The Examiner rejected claims 1, 2, 4, 5, 8-10, and 12 under 35 U.S.C.
§ 103(a) as being rendered obvious by Sirhan and Roorda. Appellants do
not argue for the separate patentability of any of these claims. We focus on
independent claim 1 in our analysis. See 37 C.F.R. § 41.37(c)(1)(vii).
II. FINDINGS OF FACT
1. Appellants’ claim 1 recites:
A medical device comprising:
a structure configured for introduction into a subject;
a base composition disposed on the structure comprising
a hydrophilic active agent;
a first separating layer disposed on the base composition,
the first layer comprising a solvent deposited polymer wherein
the first separating layer is configured to separate the base
composition from a second layer and protect the active agent;
and
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the second layer disposed on the first layer, the second
layer comprising a plasma or vapor deposited polymer and
configured to provide controlled release of the active agent
through the second layer; wherein the second layer has release
characteristics that are distinct from the first layer.

(App. Br. 12, Claims App’x).
2. Figure 3 of Appellants’ specification is reproduced below.

Figure 3 depicts a cross-sectional view of the wire of a stent, showing
multilayer coatings. (Spec. p. 7, ll. 20-21). Figure 3 includes the substrate,
or structure, of the stent (22) in the middle, surrounded by a composition that
includes an active agent (32), an intermediate layer (34), and an outer layer
(36). (Spec. p. 7, l. 20, through p. 8, l. 9).
3. Appellants provide poly(n-butyl methacrylate) and
poly(ethylene-co-vinyl acetate) as a material for the first layer. (App.
Br. 12, Claims App’x, claim 6).
4. Appellants provide poly 2-chloro-paraxylylene (parylene C),
polyparaxylylene (parylene N), or poly 2,5-dichloro-paraxylene (parylene D)
as materials for the second layer. (App. Br. 13, Claims App’x, claim 8).
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5. Sirhan teaches medical devices such as stents that can provide
an active agent. (Sirhan ¶¶ [0003] and [0015]).
6. Sirhan teaches active agents that are that same as those listed by
Appellants as useful in the claimed device (e.g., cyclosporine and
dexamethasone). (Sirhan ¶ [0043] and Spec. p. 22, l. 15, through p. 24, l. 5).
7. Figure 2I of Sirhan is reproduced below.

Figure 2I depicts a cross-sectional view of a delivery prosthesis (Sirhan
¶ [0066]) with a structure (16), an agent (28), a first rate-controlling element
(43), and a second rate-controlling element (49) formed over a matrix (40),
wherein the second rate-controlling element further affects the release rate of
the active agent (Sirhan ¶¶ [0102] and [0105]).
8. Sirhan teaches that the first and second rate-controlling
elements can be of the same or different material. (Sirhan ¶ [0105]).
9. Sirhan teaches that the rate controlling elements can be of
materials including poly-N-butyl methacrylate or parylene. (Sirhan
¶ [0035]).
10. Sirhan teaches that the rate controlling elements can be plasma
deposited polymers (Sirhan ¶¶ [0027] and [0064]), which can be deposited
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onto a stent in a vapor deposition chamber or plasma deposited coating
chamber. (Sirhan ¶ [0149]).
11. Sirhan also teaches that stents can be coated by dipping in or
spraying with a solution prepared in a solvent such as isopropyl alcohol,
ethanol, or methanol. (Sirhan ¶ [0192], Example 2). The Examiner found,
and Appellants do not dispute, that this method of coating is a form of
solvent deposition. (Ans. 4).
12. Roorda teaches vascular devices, such as stents, coated with an
active agent. (Roorda ¶ [0003]).
13. Roorda provides an example of an active agent, prednisolone,
applied to a stent in a composition with poly-(n-butyl methacrylate) and
overcoated with parylene. (Roorda ¶ [0050], Example 4). Prednisolone is
an active agent within the scope of Appellant’s claimed device. (See Spec.
p. 23, l. 8).
III. ISSUE
Would the claimed device having an active agent and two layers of
polymer have been obvious in view of Sirhan and Roorda?
IV. ANALYSIS
Appellants claim a device with a base composition comprising an
active agent covered by two layers of polymer. (FF2 1). The first layer
comprises a solvent polymer and the second layer comprises a plasma or
vapor deposited polymer. (Id.). The first layer is configured to separate the
base composition from the second layer and to protect it, and the second

2 “FF” indicates a Finding of Fact.
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layer is configured to provide controlled release of the active agent. (Id.).
Appellants’ dependent claims provide that the first layer can be poly(n-butyl
methacrylate) and poly(ethylene-co-vinyl acetate) (see FF 3, App. Br. 12,
Claims App’x, claim 6) and that the second layer can be poly 2-chloro-
paraxylylene (parylene C), polyparaxylylene (parylene N), or poly 2,5-
dichloro-paraxylene (parylene D) (see FF 4, App. Br. 12, Claims App’x,
claim 8).
Sirhan teaches a stent coated with an active agent (FFs 5 and 6; Sirhan
¶¶ [0003], [0015], and [0043]) and with two rate-controlling elements that
affect the release rate of the active agent (FF 7; Sirhan Fig. 2I and ¶¶ [0102]
and [0105]). As depicted in Figure 2I of Sirhan, the first layer (element 43)
can be positioned so that it separates the second layer (element 49) from the
base composition. (See FF 7; Sirhan Fig. 2I). Sirhan teaches that the two
rate-controlling elements can be of different materials (FF 8; Sirhan
¶ [0105]), including poly-N-butyl methacrylate or parylene (FF 9; Sirhan
¶ [0035]). In addition, Sirhan teaches both solvent deposition and plasma
deposited polymers to coat stents. (FFs 10 and 11; see Sirhan ¶¶ [0027],
[0064], [0149], and [0192]).
In KSR Int’l co. v. Teleflex, Inc., the Supreme Court explained that
[w]here there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has a good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense.

KSR Int’l co. v. Teleflex, Inc., 550 US 398, 417 (2007). The teaching in
Sirhan to include materials such as poly-N-butyl methacrylate and parylene
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to coat a stent with multiple layers, combined with its teaching that the
coating materials for those layers can be either solvent deposited or plasma
deposited, would have rendered a device having a layer of each of these
coating materials obvious. Furthermore, Roorda teaches using poly-N-butyl
methacrylate to first coat a stent with an active agent, followed by a
second layer of parylene. (FFs 12 and 13, Roorda ¶¶ [0003] and [0050],
Example 4). Appellants do not direct us to evidence that providing a first
layer of a solvent deposited polymer and a second layer of a plasma or vapor
deposited polymer would have been beyond the skill of those in the art at the
time of Appellants’ filing or would have produced unexpected results.
Appellants argue that the Examiner has erred by suggesting that
Sirhan teaches “more than one layer labeled 49” to render the claimed
device obvious. (App. Br. 9-10). Instead of relying on a layer not described
in Sirhan, the Examiner finds that Sirhan teaches that an “active agent layer
is . . . coated with rate-controlling element 43. There is then a second rate
controlling element 49 which can be made of a different material from 43.”
(Ans. 3). This description of Sirhan is supported by Figure 2I of Sirhan,
which provides layers 43 and 49. (See FF 7). Because Sirhan teaches two
layers as claimed, we are not persuaded that the Examiner erred.
Appellants also argue Sirhan teaches away from separating and
protecting the active agent from the second layer with a first layer, as
claimed, because Sirhan teaches that the active agent can be exposed to
polymers such as parylene. (App. Br. 10; see Sirhan ¶ [0149]). Similarly,
Appellants argue that Roorda teaches away from the claimed device because
it teaches depositing a mixture of poly-(n-butyl methacrylate) and
prednisolone followed by a direct coating with parylene. (App. Br. 11; see
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FF 13, Roorda ¶ [0050]). According to Appellants, this arrangement would
allow exposure of the active agent to the parylene, teaching away from the
claimed device.
“A reference may be said to teach away when a person of ordinary
skill, upon reading the reference, would be discouraged from following the
path set out in the reference, or would be led in a direction divergent from
the path that was taken by the applicant.” In re Gurley, 27 F3d 551, 553
(Fed. Cir. 1994). Appellants’ claim 1 recites that the active agent is
protected but does not require that it be protected from any particular
material such as parylene. We are not persuaded that one skilled in the art
would have been discouraged from the claimed configuration in view of
Sirhan and Roorda since the first layer in both Sirhan and Roorda provide
some separation and thus protection for the active agents. Furthermore, even
were protection from parylene a requirement of the claim, neither Sirhan nor
Roorda teaches that the layer of poly-(n-butyl methacrylate) allows contact
between all of the active agent and the parylene. Instead, Figure 2I of Sirhan
depicts the first layer 43 as separating the active agent from the second
layer 49. By mixing the poly-(n-butyl methacrylate) with the active agent,
Roorda provides that at least some of the active agent particles will be
separated from direct exposure to the parylene. Accordingly, the Examiner
did not err in rejecting claim 1 under 35 U.S.C. § 103(a) over Sirhan and
Roorda.
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V. ORDER
Upon consideration of the record and for the reasons given, the
rejection of claims 1, 2, 4, 5, 8-10, and 12 under 35 U.S.C. § 103(a) as being
rendered obvious by Sirhan and Roorda is AFFIRMED.
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)(2007).

AFFIRMED
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Pauly, Devries, Smith & Deffner, L.L.C.
Plaza VII
45 South Seventh Street, Suite 3000
Minneapolis, MN 55402-1630