Ex Parte Barry et al

Board of Patent Appeals and Interferences

Aug 31, 2010

11127499 (B.P.A.I. Aug. 31, 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.
11/127,499 05/11/2005 James J. Barry 12013/62403 6137
26646 7590 09/01/2010
KENYON & KENYON LLP
ONE BROADWAY
NEW YORK, NY 10004
EXAMINER
BROWN, COURTNEY A
ART UNIT PAPER NUMBER
1617
MAIL DATE DELIVERY MODE
09/01/2010 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 JAMES J. BARRY
and
KALPANA R. KAMATH,
Appellants1
____________________

Appeal 2010-006009
Application 11/127,499
Technology Center 1600
____________________

Before CAROL A. SPIEGEL, TONI R. SCHEINER, and
STEPHEN WALSH, Administrative Patent Judges.

SPIEGEL, Administrative Patent Judge.

DECISION ON APPEAL2

1 The real party in interest is BOSTON SCIENTIFIC SCIMED INC. (Appeal
Brief under 37 C.F.R. § 31.37 filed 24 August 2009 ("App. Br.") at 2). This
decision also cites to the Examiner's Answer mailed 20 November 2009
("Ans.") and the Reply Brief under 37 CFR 41.41 filed 20 January 2010
("Reply Br.").
2 The two-month 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.
Appeal 2010-006009
Application 11/127,499

2
Appellants appeal under 35 U.S.C. § 134(a) from an Examiner's final
rejection of all pending claims, claims 6, 8-10, 12-17, and 20-22 (App. Br. 4;
Ans. 2). We have jurisdiction under 35 U.S.C. § 134. We AFFIRM-IN-
PART.
I. Statement of the Case
The subject matter on appeal is directed to drug coated stents. Claims
6 and 20 are illustrative and read (App. Br. 14-15, emphasis added):
6. A drug coated stent comprising:
a structural member insertable into a body lumen of a
patient; and
a drug coated onto at least a portion of said structural
member;
wherein about 60 micrograms or less than about 60
micrograms of the drug is released within ten days after
insertion into the body lumen of the patient and
the release rate is maximized between 24 hours and
three days.

20. A paclitaxel coated stent comprising:
a structural member insertable into a body lumen of a
patient; and
paclitaxel coated onto at least a portion of said structural
member;
wherein about 10 micrograms or less than 10 micrograms
of paclitaxel is released from said stent two days after exposure
to an aqueous environment; and
the release rate is maximized between 24 hours and
three days.

The Examiner rejected claim 6 on the ground of nonstatutory
obviousness-type double patenting as unpatentable over claims 1-4 of U.S.
Patent 6,908,6223 (Ans. 3-4). Since Appellants have not appealed this

3 U.S. Patent 6,908,622 B2, Optimized Dosing for Drug Coated Stents,
issued 21 June 2005, to James J. Barry and Kalpana R. Kamath.
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Application 11/127,499

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rejection (App. Br. 7), we summarily affirm the rejection of claim 6 as
unpatentable on the ground of nonstatutory obviousness-type double
patenting over claims 1-4 of U.S. Patent 6,908,622.
The Examiner also rejected claims 6, 8-10, 12-17, and 20-22 as
unpatentable under 35 U.S.C. § 103(a) over Ragheb4 in view of Ding5 (Ans.
5-8).
The Examiner found that Ragheb discloses a slow-release paclitaxel
coated stent which releases 0.75 µg paclitaxel/day for the first 30 days, but
did not expressly teach that the drug release rate was maximal between 24
hours and three days (Ans. 6). However, the Examiner found that Ding
teaches time-release drug-coated stents having a maximal drug release at
19.2 hours (id. at 6-7). According to the Examiner, a maximal 1-3 day
release rate is intrinsic in the zero order release rate of Ragheb and Ding
teaches that a desired release rate and profile can be obtained by varying the
thickness of the outer [drug] layer as well as the concentration of ionically
bound drug in that layer (id. at 8-9). Thus, the Examiner concluded that it
would have been obvious "to make a paclitaxel coated stent wherein about
60 micrograms of the drug is released within ten days after insertion into to
the body lumen of a patient and the release rate is maximized between 24
hours and three days," as a "matter of judicious selection and routine
optimization" to have a maximal release rate at 24 hours to 3 days (id. at 7,

4 U.S. Patent 6,299,604 B1, Coated Implantable Medical Device, issued 9
October 2001, based on application 09/378,541, filed 20 August 1999, to
Ragheb et al. ("Ragheb").
5 U.S. Patent 5,879,697, Drug-Releasing Coatings for Medical Devices,
issued 9 March 1999 to Ding et al. ("Ding").
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9). The Examiner also notes that claim 16 of Ragheb recites a device
comprising at least 35 µg of paclitaxel (id. at 12).
Appellants argue that (i) Ragheb discloses a steady (not maximized)
release rate for paclitaxel, (ii) Ding discloses a release rate for heparin that is
maximized in less than 24 hours, and (iii) given the difference in structure
and function between paclitaxel and heparin, one of ordinary skill in the art
would not deliver paclitaxel at the same rate as heparin or vice versa (App.
Br. 8-12). Appellants further argue that at a steady release rate of 0.75 µg
paclitaxel/day, the stent of Ragheb would have released 7.5 µg paclitaxel in
ten days which is more than the 6 µg or 4 µg paclitaxel release in ten days
recited in claims 16 and 17, respectively (id. at 10).
The dispositive issue is whether the evidence of record teaches or
suggests optimizing drug release from a drug-coated stent to obtain maximal
release between 1 and 3 days.
II. Findings of Fact
The following findings of fact are supported by a preponderance of
the evidence of record.
[1] Ragheb discloses a stent coated with a porous layer containing a first
bioactive material, such as paclitaxel, wherein the coating layer
provides for a controlled release of the bioactive material (Ragheb col.
3, ll. 7-18; col. 10, ll. 34-42).
[2] According to Ragheb, "GR IIâ„¢ stents coated with 'slow release'
paclitaxel (175-200 µg total drug with in vitro release kinetics of 0.75
µg/day for the first 30 days) significantly reduced in-stent restenosis
compared with controls …" (id. at col. 14, ll. 59-63).
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[3] Further according to Ragheb, "[s]ubsequent study data with two doses
of 'fast-release' paclitaxel showed that both 'low-dose' and 'high-dose'
paclitaxel-coated stents significantly reduced in-stent restenosis
compared to control stents …" (id. at col. 15, ll. 13-16).
[4] Ding discloses a stent having a drug-releasing coating comprising at
least two layers: a reservoir layer and an outer layer comprising an
ionic surfactant complexed to a biologically active material (Ding col.
1, ll. 6-12; col. 4, ll. 58-67; col. 5, ll. 1-3).
[5] According to Ding, as ionically-complexed drug in the outer layer is
released into body fluid upon contact, additional amounts of drug
from the reservoir layer form a complex with vacant complex sites of
the ionic surfactant of the outer layer to provide a sustained release of
the drug (id. at col. 2, l. 59- col. 3, l. 13).
[6] Further according to Ding, the concentration or loading of the drug in
the reservoir layer, the thickness of the outer layer, and the
concentration of ionically bound drug in the outer layer can be varied
according to the therapeutic effects desired (id. at col. 6, ll. 54-56; col.
9, ll. 1-6).
[7] Figure 1 of Ding shows the release rate of heparin for stents with
coatings made according to its Example 1 and is reproduced below.
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{Figure 1 of Ding is a plot of the release rate of a heparin-coated stent.}

[8] According to Example 1 of Ding, heparin release was measured by an
Azure A Assay at 0.1, 0.8, 2.4, 3.8, 5.8, and 7.7 days (id. at col. 10, l.
47-col. 11, l. 3; Table 1b).
III. Discussion
A. Legal principles
"The test of obviousness vel non is statutory. It requires that one
compare the claim's 'subject matter as a whole' with the prior art 'to which
said subject matter pertains.' 35 U.S.C. § 103. The inquiry is thus highly
fact-specific by design. This is so 'whether the invention be a process for
making or a process of using, or some other process.'" In re Brouwer, 77
F.3d 422, 425 (Fed. Cir. 1996). In KSR Int'l Co. v. Teleflex, Inc., 550 U.S.
398, 418 (2007) (citing In re Kahn, 441 F.3d 997, 988 (Fed. Cir. 2006)), the
Supreme Court noted that "[t]o facilitate review, this [obviousness] analysis
should be made explicit."
Furthermore, obviousness requires a suggestion of all limitations in a
claim. In re Royka, 490 F.2d 981, 985 (CCPA 1974).
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B. Analysis
Here, all of the claims on appeal require the release rate of the drug
coated on the stent to be "maximized between 24 hours and three days." The
Examiner has not pointed to evidence of record teaching or suggesting the
drug release should be maximal between 24 hours and three days after the
stent is inserted into a body lumen of a patient. To the contrary, Ding, the
only reference to describe the rate release of a drug coated onto a stent,
shows a falling release rate which appears to level off at about 2.4 days (FF
7-8). Since the Examiner has not explicitly explained why "it would be
obvious … to modif[y] Ragheb to have a non-steady release rate with a
maximization peak" as peak as claimed (Ans. 11), we are constrained to
reverse the rejection of claims 6, 8-10, 12-17, and 20-22 under § 103 over
Ragheb in view of Ding.
C. Conclusion
We reverse the rejection of claims 6, 8-10, 12-17, and 20-22 as
obvious over Ragheb in view of Ding. The evidence of record fails to teach
or suggest optimizing drug release from a drug-coated stent to obtain
maximal release between 1 and 3 days.
IV. Order
Upon consideration of the record, and for the reasons given, it is
ORDERED that the decision of the Examiner to reject claim 6 on the
ground of nonstatutory obviousness-type double patenting as unpatentable
over claims 1-4 of U.S. Patent 6,908,622 is AFFIRMED;
FURTHER ORDERED that the decision of the Examiner to reject
claims 6, 8-10, 12-17, and 20-22 as unpatentable under 35 U.S.C. § 103(a)
over Ragheb in view of Ding is REVERSED; and,
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FURTHER ORDERED that 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).
AFFIRMED-IN-PART

cdc
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