Ex Parte Faour et al

Board of Patent Appeals and Interferences

May 16, 2011

10851866 (B.P.A.I. May. 16, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JOAQUINA FAOUR and JUAN A. VERGEZ
__________

Appeal 2010-010266
Application 10/851,866
Technology Center 1600
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Before ERIC GRIMES, MELANIE L. McCOLLUM, and
STEPHEN WALSH, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
controlled release device. The Examiner has rejected the claims on appeal
as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
Claims 1-7, 9-12, 15-17, and 19-64 are pending and on appeal (App.
Br.
1
4). Claim 1 is representative and reads as follows:

1
Supplemental Appeal Brief filed November 2, 2009.
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Application 10/851,866

2
1. A rupturing controlled release device comprising: a) a core
comprising an active agent and, optionally, at least one excipient, and b) a
wall enclosing the core and having a weakened section and a preformed
passageway there through, wherein the wall ruptures at the weakened section
during use due to an increase of internal osmotic pressure of the core during
use of the device to form a second passageway by breakage of the wall at a
location spaced away from the preformed passageway such that active agent
is released over an extended period of time from both passageways.
Claims 1-7, 9-12, 15-17, and 19-64 stand rejected under 35 U.S.C.
§ 103(a) as obvious over Faour
2
in view of Penhasi,
3
Chen,
4
and Paul
5

(Ans. 3).
Claims 1-7, 9-12, 15-17, and 19-64 stand rejected under 35 U.S.C.
§ 103(a) as obvious over Ayer
6
in view of Penhasi, Chen, and Paul (id. at 8).
In the first rejection, the Examiner relies on Faour for disclosing a
“multi-layered osmotic device that is capable of delivering a first active
agent in the outer lamina to the environment of use and second active agent
in the core to another environment of use” (id. at 3). The Examiner finds
that the “active agent in the core is delivered through [a] pore containing an
erodible plug” (id. at 3-4). The Examiner also finds that Faour “teaches that
the device can comprise more than one passageway” and “that active
agents can be released in a controlled manner” (id. at 4).
In the second rejection, the Examiner relies on Ayer for disclosing “an
osmotic device for the delivery of two active agents . . . in a rate controlled

2
Faour et al., US 6,004,582, Dec. 21, 1999.
3
Penhasi et al., US 6,632,451 B2, Oct. 14, 2003.
4
Chen et al., US 5,558,879, Sep. 24, 1996.
5
Paul Wan Sia Heng et al., Mechanism of Pellet Coat Rupture and Its Effect
on Drug Release, 47 CHEM. PHARM. BULL. 939-943 (1999).
6
Ayer et al., US 4,810,502, Mar. 7, 1989.
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manner” (id. at 8). The Examiner finds that “passageways have been
disclosed to include aperture, bore, pores or porous element through which
the drugs can migrate” and that “the device may contain one or more
passageways” (id. at 10).
In both rejections, the Examiner relies on Penhasi for teaching “a
gastrointestinal (GI) delivery system (e.g. a tablet) comprising a core
material comprising an active ingredient and a „swelling material‟,
encapsulated by an inner coat and then an outer coat comprising an active
ingredient” (id. at 5). The Examiner finds that the “agent in the outer coat is
released immediately or in a sustained release fashion” and that the “release
of the agent from the outer coat triggers a „bursting of the core‟ resulting in
the release of the active agent from the core” (id.). The Examiner also finds
that Penhasi “teaches that the particulate matter in the inner coat takes up
liquid, thus forming channels interconnecting the drug - containing core
with the outside of the delivery device, through these channels liquid enters
the core which then swells to the point at which the inner coat is broken”
(id. at 5-6). In addition, the Examiner finds that Penhasi shows “how one of
ordinary skill in the art would have envisaged to utilize the membrane with
weakened section in order to effect the creation of second passageways and
eventual release/bursting of active ingredients from those channels or
passageways formed during use of the device” (id. at 17).
“With regard to the passageway formed in situ, [the Examiner finds
that] Chen et al. teaches a controlled release pharmaceutical osmotic tablet
with no preformed aperture in which a passageway is formed in situ” (id. at
6 & 10). In particular, the Examiner finds that “[d]ue to [an] increase in the
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osmotic pressure . . . small opening are [sic] formed at the weakest points in
the membrane” (id.).
“With regard to the mechanism of coat rupturing, [the Examiner finds
that] Paul et al. teaches [the] mechanism of pellet coat rupture and its effect
on drug release” (id.). In particular, the Examiner finds that, “[a]mong the
various factors which govern the rupture of the coat, the level of pore
forming agents in the coat correlate to bursting strength” and that, “[w]ith
sodium chloride and HPMC in the diffusion coat, the bursting of the pellet
was delayed” (id. at 6-7 & 10-11).
The Examiner concludes that it would have been obvious to modify
Faour or Ayer “by incorporating [an] inner coat which forms channels
interconnecting the drug containing core with the outside of the delivery
device which when imbibed by liquid during use would break and deliver
the drug to the specific site as taught by Penhasi” because each of Faour and
Ayer suggests “that the device can have more passageways and Penhasi et
al. teach[es the] creation of channels (which reads on more passageways as
claimed in the instant invention) during use of [an] osmotic device” (id. at 7
& 11). The Examiner also concludes that it would have been obvious “to
modify the osmagent and excipients such as sodium chloride and HPMC and
various excipients such as plasticizers as taught by [Faour or Ayer] in order
to effect the rupturing of the coat during drug release motivated by the
teachings of Paul” and,
in view of Chen et al. disclosing the formation of [a] . . .
passageway due to the weak points and applying the teachings
of Penhasi et al., disclosing various channels being formed
during use of the osmotic device, a skilled artisan would have
been motivated to prepare an osmotic device comprising a
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weakened section which would create a second passageway
during use of the device in order to effect delivery of drug to
specific sites with a reasonable expectation of success.
(Id. at 7-8 & 11-12.)
Appellants contend that, “[b]ased upon the purposeful and different
modes of operation of the devices of Faour et al. and Penhasi et al., . . . there
would be no basis for the prophetic combination thereof” (App. Br. 12).
Appellants also contend:
Since formation of a passageway (Chen et al. and Paul et al.) or
bursting of the device (Paul et al.) is the means by which
internal pressure is relieved, an artisan would not expect the
device of Faour et al., which already has a preformed
passageway (for releasing drug and relieving pressure), to be
capable of rupturing or could even be modified to rupture
during use as long as the preformed passageway was present.
(Reply Br. 10 (emphasis omitted).) In addition, Appellants contend that
Ayer “does not add anything more of relevance over the disclosure of
Faour” (id. at 14).
ISSUE
Does the evidence support the Examiner‟s conclusion that the
controlled release device of claim 1 would have been obvious?
FINDINGS OF FACT
1. Faour discloses a “multi-layered osmotic device (1) that is
capable of delivering a first active agent in an outer lamina (2) to one
environment of use and a second active agent in the core (5) to another
environment of use” (Faour, Abstract).
2. Faour also discloses that the “active agent in the core (5) is
delivered through a pore (6) containing an erodible plug (7)” (id.).
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3. In addition, Faour discloses that the device “can comprise at
least one or more passageways including two, three, four, five, six, seven,
eight, nine, ten or more passageways” (id. at col. 8, ll. 64-67).
4. Ayer discloses an osmotic dosage form 10 comprising “wall 13
that surrounds and defines an internal compartment 14” and “comprises at
least one exit port 16, or more than one exit port means for dispensing the
contents of compartment 14 from dosage form 10” (Ayer, col. 4, ll. 4-13).
5. Ayer also discloses that “compartment 14 houses a dispensable
composition comprising the beneficial drugs” (id. at col. 6, ll. 26-28).
6. Chen discloses “an osmotic tablet that is designed to provide
once a day dosing of water soluble drugs but does not have a pre-formed
osmotic passageway” (Chen, col. 1, ll. 63-66).
7. Chen also discloses:
[I]t is believed that the use of the plasticizer in combination
with the water insoluble polymer to form the external
membrane around the core of the tablet, results in a membrane
which will allow water to be imbibed into the core of the tablet
even in the absence of a preformed aperture. As water is taken
up into the core of the tablet, the medicament and the water
soluble osmotic agent dissolve which causes an increase in the
osmotic pressure inside the tablet. This causes a small opening
to form at the weakest point in the membrane which is at the
edge of the tablet. Once the initial opening is formed at a single
point, the osmotic effect of the core components in commences
to extrude the contents of the core through the initial opening.
The internal pressure which is exerted on the membrane by the
osmotic core is relieved by the passage of the first portion of
the core contents through the initial opening and no other
opening is observed.
(Id. at col. 3, ll. 35-52.)
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PRINCIPLES OF LAW
An invention “composed of several elements is not proved obvious
merely by demonstrating that each of its elements was, independently,
known in the prior art.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418
(2007). It “can be important to identify a reason that would have prompted a
person of ordinary skill in the relevant field to combine the elements in the
way the claimed new invention does.” Id. In addition, an “obviousness
determination requires that a skilled artisan would have perceived a
reasonable expectation of success in making the invention in light of the
prior art.” Amgen Inc. v. F. Hoffman-LA Roche Ltd, 580 F.3d 1340, 1362
(Fed. Cir. 2009).
ANALYSIS
Faour and Ayer each discloses an osmotic device comprising a core
comprising an active agent and a wall enclosing the core having a preformed
passageway therethrough (Findings of Fact (FF) 1-2 & 4-5). Faour and Ayer
each also discloses that its device can contain a second passageway (FF 3-4).
However, it is undisputed that neither Faour nor Ayer teaches that this
second passageway is formed when the wall ruptures at a weakened section
due to an increase of internal osmotic pressure of the core during use of the
device (Ans. 5 & 10). In addition, for the reasons stated in the Appeal and
Reply Briefs, we agree with Appellants that none of Penhasi, Chen, and Paul
suggests including a weakened section in Faour‟s or Ayer‟s device with a
reasonable expectation of producing a device having the claimed first and
second passageways.
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In particular, Chen discloses an osmotic device comprising a core
comprising an active agent and a wall enclosing the core having a weakened
section, wherein, during use, “an increase in the osmotic pressure inside the
tablet . . . causes a small opening to form at the weakest point in the [wall]”
(FF 6-7). However, Chen discloses that its device “does not have a pre-
formed osmotic passageway” (FF 6). In addition, Chen discloses that the
“internal pressure which is exerted on the membrane by the osmotic core is
relieved by the passage of the first portion of the core contents through the
initial opening and no other opening is observed” (FF 7). Thus, we agree
with Appellants that the teachings of Chen suggest that its passageway
would not be formed in Faour‟s or Ayer‟s device because passage of the
core contents through the preformed passageway would relieve the internal
pressure needed to form a second passageway.
CONCLUSION
The evidence does not support the Examiner‟s conclusion that the
controlled release device of claim 1 would have been obvious. We therefore
reverse both of the obviousness rejections of claim 1 and of claims 2-7, 9-12,
15-17, 19-42, and 45-64, which depend from claim 1. For the same reasons,
we reverse both of the obviousness rejections of method claims 43 and 44,
which both require providing a controlled release device like that defined by
claim 1.

REVERSED

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