Ex Parte Hossainy et al

Board of Patent Appeals and Interferences

Nov 5, 2010

10108004 (B.P.A.I. Nov. 5, 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.
10/108,004 03/27/2002 Syed F.A. Hossainy 50623.199 7790
44955 7590 11/05/2010
SQUIRE, SANDERS & DEMPSEY L.L.P.
275 BATTERY STREET, SUITE 2600
SAN FRANCISCO, CA 94111-3356
EXAMINER
PELLEGRINO, BRIAN E
ART UNIT PAPER NUMBER
3738
MAIL DATE DELIVERY MODE
11/05/2010 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 SYED F.A. HOSSAINY, GORDON STEWART,
MARK A. WILLIAMS, JEFF ROYAL, PAUL M. CONSIGNY,
DORRIE M. HAPP, KURT SCHEINPFLUG and TY HU
____________________

Appeal 2009-007316
Application 10/108,004
Technology Center 3700
____________________

Before JENNIFER D. BAHR, JOHN C. KERINS and
STEVEN D.A. McCARTHY, Administrative Patent Judges.

McCARTHY, Administrative Patent Judge.

DECISION ON APPEAL1

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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STATEMENT OF THE CASE
The Appellants’ claims being twice rejected, the Appellants appeal
under 35 U.S.C. § 134 from the Examiner’s decision rejecting claims 1, 3-8
and 21-25. The Examiner withdrew claims 9-16, 19 and 20 from
consideration. We have jurisdiction under 35 U.S.C. § 6(b).
More specifically, the Examiner rejects claims 1, 3-8 and 21-25 under
35 U.S.C. § 112, first paragraph, for failure to comply with the written
description requirement; claims 6-8 under 35 U.S.C. § 112, second
paragraph, as indefinite; claims 1, 4-7 and 21-24 under 35 U.S.C. § 103(a) as
being unpatentable over Carlyle (US 2002/0127263, publ. Sep. 12, 2002);2
claim 3 under § 103(a) as being unpatentable over Carlyle and Pacetti (US
6,743,462 B1, issued Jun. 1, 2004); and claims 8 and 25 under § 103(a) as
being unpatentable over Carlyle and Hossainy (EP 0 970 711 A2, publ. Jan.
12, 2000).
We REVERSE.
Claims 1 and 6 are independent. Claim 1 recites:
1. A stent for implantation in a human
being having a vascular medical condition,
comprising a radially expandable body and a
coating covering at least a portion of the body, the
coating containing 40-O-(2-hydroxy)ethyl-
rapamycin, wherein the amount of the 40-O-(2-
hydroxy)ethyl-rapamycin-released in 24 hours
after the implantation of the stent in a blood vessel
of a human being is less than about 50% of the
total amount of 40-O-(2-hydroxy)ethyl-rapamycin-
contained in the coating.

2 The Examiner withdrew in the Answer an alternative rejection of
claims 1, 4-7 and 21-24 under 35 U.S.C. § 102(e) as being anticipated by
Carlyle. (See Ans. 3).
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Claim 6 recites a method “comprising implanting in a blood vessel of the
patient a stent which releases 40-O-(2-hydroxy)ethyl-rapamycin at an
amount less than 50% of the total amount of the 40-O-(2-hydroxy)ethyl-
rapamycin carried by the stent in a 24 hour period following the
implantation procedure in the blood vessel of the human being.”

OPINION
Rejection of Claims 1, 3-8 and 21-25 under § 112, First Paragraph, for
Failure to Comply with the Written Description Requirement
In rejecting independent claims 1 and 6 under § 112, first paragraph,
the Examiner states that the “limitation that the implantation of the stent in a
blood vessel of a human being releases less than 50% of the total amount of
rapamycin in the coating is not supported. Although some examples may
show less than 50% is released after 24 hours (implanted) in the
specification, these trials were based on animals.” (Ans. 4). The Appellant
responds that, while “implantation in a blood vessel of a human being is not
expressly stated in the specification, it would be absolutely clear and
unambiguous to one of ordinary skill in the art that such is the purpose of the
invention.” (App. Br. 4).
The written description requirement is met if “the disclosure of the
application relied upon reasonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter as of the filing date.”
Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir.
2010)(en banc). There is no requirement either that a specification describe
claimed subject matter in haec verba, Ariad Pharms. at 1352, or that the
specification contain examples explicitly covering the full scope of the claim
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language, Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1366 (Fed. Cir.
2006).
The Specification states that the “device or prosthesis coated in
accordance with embodiments of the present invention may be any suitable
medical substrate that can be implanted in a human or veterinary patient.”
(Spec. 32, ll. 13-15). Given this statement, one of ordinary skill in the art
would have understood that the Appellants intended the method of claim 6
to be practiced on human patients. One of ordinary skill in the art also
would have understood that the Appellants expected the release rates of 40-
O-(2-hydroxy)ethyl-rapamycin from the stents when implanted in human
blood vessels to be similar to the release rates described in the examples
disclosed in the Specification.
No persuasive showing has been made that the Specification would
have failed to reasonably convey to one of ordinary skill in the art that the
Appellants possessed the claimed subject matter as of the filing date. We do
not sustain the rejections of independent claims 1 and 6, or of dependent
claims 3-5, 7, 8 and 21-25, under § 112, first paragraph, for failure to
comply with the written description requirement.

Rejection of Claims 6-8 under § 112, Second Paragraph, as Indefinite
The Examiner concludes that claim 6 is indefinite because the term
“the human being” at the end of the claim lacks adequate antecedent basis.
(Ans. 4). The Appellants respond that the antecedent basis for the term “the
human being” at the end of claim 6 is the term “a patient” as used in the
preamble. The Appellants further respond that, even without this antecedent
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basis, the scope of the claims would be clear when read in light of the
Specification. (App. Br. 6-7).
Lack of antecedent basis is not a sufficient basis for rejecting a claim
as indefinite unless one of ordinary skill in the art would not understand the
bounds of the claim as whole when read in light of the Specification.
Energizer Holdings, Inc. v. Int’l Trade Comm’n, 435 F.3d 1366, 1370-71
(Fed. Cir. 2006). Here, one of ordinary skill in the art would understand the
term “the human being” to limit the term “a patient” as used in the preamble
and the term “the patient” as used in the claim body to a human patient. The
Appellant concedes that the term “the human being” and the term “patient”
as used in claim 6 “are simply different descriptors of one and the same
object: a human being patient.” (Reply Br. 3). We do not sustain the
rejection of independent claim 6, or of dependent claims 7 and 8, under
§ 112, second paragraph, as being indefinite.

Rejection of Claims 1, 4-7 and 21-24 under § 103(a) as Being Unpatentable
Over Carlyle; of Claim 3 under § 103(a) as Being Unpatentable Over
Carlyle and Pacetti; and of Claims 8 and 25 under § 103(a) as Being
Unpatentable Over Carlyle and Hosseiny
In rejecting claims 1 and 6, the Examiner finds that Carlyle discloses a
stent including a radially expandable body and a coating covering at least a
portion of the body. The Examiner additionally finds that the coating
contains 40-O-(2-hydroxy)ethyl-rapamycin. (Ans. 4). The Examiner
concludes that it would have been obvious
to design the drug coated stent to release less than
50% of the 40-O-(2-hydroxy)ethyl-rapamycin
from the coating after 24 hours of implantation
since such a modification only involves routine
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skill in the art. Although not explicitly stated,
Carlyle provides optimal conditions using human
cells to test the release of the drug from the
polymer.
(Ans. 5).
Carlyle discloses complexing the thiazolidinediones with suitable
biocompatible polymers and then using the polymer-drug complexes to coat
medical devices such as stents for implantation into the blood vessels of
human beings. (Carlyle, para. [0011]). Carlyle also teaches delivering the
thiazolidinediones in combination with “synergistic and/or additive
therapeutic agents, directly to the affected area.” (Carlyle, para. [0028]).
Carlyle discloses that such “synergistic” combinations include “at least one
thiazolidinedion[e] and rapamycin or analogues and derivatives thereof such
a[s] 40-O-(2-hydroxyethyl)-rapamycin.” (Id.)
The Examiner concedes that “Carlyle does not explicitly state that
after 24 hours of being implanted in a human being blood vessel that there
would be less than about 50% of the rapamycin released than the amount
that was in the coating.” (Ans. 5). Instead, the Examiner finds that:
an expert in polymer chemistry is capable of
determining the optimal release rate for a drug
from a polymer based on the statement of Carlyle
that “it is possible for one of ordinary skill in the
[art] of polymer chemistry to design coatings
having a wide range of dosages and administration
rates” from paragraph 35. It is also common sense
that releasing a drug too fast has no effect at the
target site if it is absorbed immediately into the
bloodstream to combat a cellular response that
takes place at a slower rate to the implantation of
the stent.
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(Ans. 8). Based on these findings, the Examiner concludes that
“optimization of the release rate must be considered.” (Id.) In other words,
the Examiner appears to reason that it would have been obvious to modify
Carlyle’s stent to optimize the release rate of the 40-O-(2-hydroxy)ethyl-
rapamycin from the polymer coating, thereby meeting the “wherein”
limitation at the end of claim 1 and the “which releases” limitation at the end
of claim 6.
The Appellant argues that, although one of ordinary skill in the art
might have had reason to optimize the release rate of thiazolidinedione from
Carlyle’s stent, one of ordinary skill in the art would not have had reason to
attempt to optimize the release rate of the 40-O-(2-hydroxy)ethyl-rapamycin
combined with the thiazolidinedione on surface of the stent. (See Reply Br.
3-6).
The optimum value of a variable in an otherwise known process is
normally obvious. In re Antonie, 559 F.2d 618, 620 (CCPA 1977)(citing In
re Aller, 220 F.2d 454, 456 (CCPA 1955)). This is not the case where the
variable to be optimized was not recognized as a result-effective variable,
however. (Id.) As the Appellant points out, “the use of thiazolidinediones is
at the very core of Carlyle; everything else is ancillary.” (Reply Br. 4). One
of ordinary skill in the art might have reason to fabricate Carlyle’s stent to
optimize the release rate of thiazolidinedione. Nevertheless, in view of
Carlyle’s focus on the release of thiazolidinedione from the stent, one of
ordinary skill in the art would have no clear reason to fabricate the stent in
order to optimize the release rate of 40-O-(2-hydroxy)ethyl-rapamycin
independently of the thiazolidinedione. The release rate of 40-O-(2-
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hydroxy)ethyl-rapamycin is not a result-effective variable in the context of
Carlyle’s disclosure.
Therefore, the Examiner’s reasoning in support of the rejection of
independent claims 1 and 6 lacks rational underpinning. We do not sustain
the rejection of claims 1, 4-7 and 21-24 under 35 U.S.C. § 103(a) as being
unpatentable over Carlyle.
Pacetti discloses a method for forming a coating for an implantable
medical device such as a stent. (Pacetti, col. 1, ll. 59-61). Pacetti further
discloses that the composition used to form the coating may include a
polymer such as an ethylene vinyl alcohol copolymer. (Pacetti, col. 1, l. 66
– col. 2, l. 1). The Examiner cites Pacetti as teaching that “a stent can be
coated with the copolymer ethylene vinyl alcohol having the drug rapamycin
therein to use for treating a diseased site.” (Ans. 6). The Examiner provides
no reasoning which might explain how the teachings of Pacetti might
remedy the defects in the teaching of Carlyle discussed with regard to the
rejection of claims 1 and 6. We do not sustain the rejection of claim 3 under
§ 103(a) as being unpatentable over Carlyle and Pacetti.
Hossainy discloses a process for coating medical devices such as
stents. (See Hossainy, paras. [0016]-[17]). Hossainy discloses applying one
or more layers of polymer when coating the stents. (Hossainy, para. [0028]).
For example, Hossainy discloses incorporating a pharmaceutical agent into a
polymer coating for release after the stent is implanted. Hossainy states that
the pharmaceutical agent may represent about 0.001 % to about 70% by
weight of the coating. (Hossainy, para. [0033]). Hossainy also discloses a
applying a top coating of polymer to delay release of a pharmaceutical agent
from a lower polymer coating or to deliver a pharmaceutically active
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material different from the pharmaceutical agent released by the lower layer.
(Hossainy, para. [0029]). Hossainy teaches that the top coating will
generally be less than about 2000 μg. (Id.)
The Examiner cites Hossainy for these teachings, concluding that it
would have been obvious to use an 40-O-(2-hydroxy)ethyl-rapamycin
amount “in the range of 50 μg to 500 μg based on the teachings of Hossainy
to place on the coated stent of Carlyle et al. such that it provides the
effective therapeutic effect.” (Ans. 6). The Examiner provides no reasoning
which might explain how the teachings of Hossainy might remedy the
defects in the teaching of Carlyle discussed with regard to the rejection of
claims 1 and 6. We do not sustain the rejection of claims 8 and 25 under
§ 103(a) as being unpatentable over Carlyle and Hossainy.

DECISION
We REVERSE the Examiner’s decision rejecting claims 1, 3-8 and
21-25.

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REVERSED

Klh

SQUIRE, SANDERS & DEMPSEY L.L.P.
275 BATTERY STREET, SUITE 2600
SAN FRANCISCO, CA 94111-3356
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