Ex Parte Odidi et al

Board of Patent Appeals and Interferences

Jul 30, 2012

09947464 (B.P.A.I. Jul. 30, 2012)

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.
09/947,464 09/07/2001 Isa Odidi 9577-27 LAB 6918
7590 07/31/2012
Dr. Lola A. Bartoszewicz
Sim & McBurney
6th Floor
330 University Avenue
Toronto, ON M5G 1R7
CANADA
EXAMINER
GRAY, PHILLIP A
ART UNIT PAPER NUMBER
3767
MAIL DATE DELIVERY MODE
07/31/2012 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 ISA ODIDI and AMINA ODIDI
____________________

Appeal 2011-008730
Application 09/947,464
Technology Center 3700
____________________

Before: JENNIFER D. BAHR, WILLIAM V. SAINDON, and
MICHAEL J. FITZPATRICK, Administrative Patent Judges.

BAHR, Administrative Patent Judge.

DECISION ON APPEAL

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STATEMENT OF THE CASE
Isa Odidi and Amina Odidi (Appellants) appeal under 35 U.S.C. § 134
from the Examiner’s decision rejecting claims 1 and 3-32. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
The Claimed Subject Matter
Claim 1, reproduced below, is illustrative of the claimed subject
matter.
1. A controlled release delivery device comprising:
- a housing adapted for oral administration;
- a plurality of discrete vehicles assembled within said
housing;
- each of said vehicles being detached from each other;
- each of said vehicles comprising a different
combination and/or amount of an active agent, an amino acid, a
buffer, and a polymer, such that each of said vehicles comprises
a different active agent and/or release property from each other;
- each of said vehicles releasing said active agent
independently of each other; and
- each of said vehicles being independently provided as a
plurality of granules compressed into a preselect shape; a bead;
a pellet; or a tablet;
- wherein each of said vehicles remains independent from
each other and intact within said housing prior to oral
administration of said delivery device.
Evidence
The Examiner relied on the following evidence in rejecting the claims
on appeal:
Bhutani
Zentner
Ibsen
Dunn
Giannos
US 4,684,516
US 4,851,228
US 5,288,500
US 5,681,581
US 6,068,853
Aug. 4, 1987
Jul. 25, 1989
Feb. 22, 1994
Oct. 28, 1997
May 30, 2000
Shaked US 2002/0110590 A1 Aug. 15, 2002
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Rejections
Appellants request our review of the following rejections under 35
U.S.C. § 103(a) by the Examiner:
(1) claims 1, 3-6, 8-11, 13, 14, 18, 23, 25, 27, and 29-31 as unpatentable
over Bhutani and Ibsen;
(2) claims 7, 12, 19-24, 26, 28, and 32 as unpatentable over Bhutani,
Ibsen, and Shaked;
(3) claim 15 as unpatentable over Bhutani, Ibsen, and Dunn;
(4) claim 16 as unpatentable over Bhutani, Ibsen, and Zentner; and
(5) claim 17 as unpatentable over Bhutani, Ibsen, and Giannos.
OPINION
Rejections (1) and (3)-(5)
In contesting rejection (1), Appellants do not assert any separate
arguments for claims 3-6, 8-11, 13, 14, 18, 23, 25, 27, and 29-31 apart from
those asserted for claim 1. Thus, in accordance with 37 C.F.R.
§ 41.37(c)(1)(vii) (2011), we select claim 1 as representative, and the
remaining claims stand or fall with claim 1.
The Examiner found that Bhutani discloses the invention of claim 1
except for each of the discrete vehicles (pellets 15) comprising an active
agent, an amino acid, a buffer, and a polymer.1 See Ans. 4-5. The Examiner
found that Ibsen discloses a vehicle comprising an active agent, an amino

1 Bhutani discloses the pellets comprising an active agent and a polymer.
See col. 6, ll. 39-40 (describing a medicament coating 11); col. 7, l. 30 – col.
8, l. 18 (describing representative pharmaceuticals of use in Bhutani’s
pellets); col. 4, ll. 20-21 (describing coating the pellets with layers of
disintegrating agents); col. 8, ll. 20, 42-44 (describing water-insoluble
polymers for use in the “disintegrating or swelling agents” coated onto the
pellets).
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acid, a buffer, and a polymer. Ans. 5. The Examiner determined it would
have been obvious
to modify the system as taught by Bhutani with discrete
vehicles comprising an active agent[,] amino acid, buffer, and
polymer as taught by Ibsen, since such a modification would
provide the system with discrete vehicles comprising an active
agent[,] amino acid, buffer, and polymer for providing
acceptable flavoring, coloring, dissolution, viscosity, and
administration environment of the device to the patient.
Ans. 5.
We have considered Appellants’ arguments contesting the Examiner’s
determination that Bhutani and Ibsen render obvious the subject matter of
claim 1, but we do not find them persuasive.
Appellants contest the Examiner’s finding that Bhutani’s pellets are
“discrete” once they have been compressed to form a tablet. App. Br. 17;
Reply Br. 15-16. Appellants’ arguments are not convincing. Bhutani
discloses that the pellets 15, after being coated with retarding wax 12 and
disintegrant materials 13, are “somewhat flattened by the compression force
of the tablet press during the tabletting, but due to the nature of the coating
materials and the layer of disintegrants, the integrity of the retarding coating
is essentially maintained.” Col. 6, ll. 54-59. Bhutani also discloses that the
“compressed tablet, when tested in water or gastric [fluid], breaks up quickly
thereby releasing the individual pellets in a matter of minutes, whereupon
they act as independent pellets releasing their medicine at a predetermined
rate.” Col. 4, ll. 24-28. These disclosures support the Examiner’s finding
that the pellets remain discrete after they have been compressed to form the
tablet. See Ans. 10 (proffering a definition of “discrete,” which has not been
contested by Appellants, as “separate or distinct in form or concept” or
“consisting of distinct or separate parts”).
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Appellants also argue that the exterior surface 16 of Bhutani’s pellet is
not a “housing.” App. Br. 17; Reply Br. 17; see Ans. 4 (citing reference
numeral “16” as denoting the housing). We agree with Appellants that the
exterior surface 16, which Bhutani describes as “not an applied coating as
such, but . . . the hard compressed surface area which results from the force
of the tablet press on the pellets” (col. 6, ll. 59-62), is not a housing.
However, the Examiner found that “the coating elements of Bhutani (such as
18 or 19) ‘cover and protect’ the interior elements of the Bhutani device,”
and thus constitute a “housing” as construed by the Examiner. Ans. 11.
Appellants do not dispute the Examiner’s finding that Bhutani’s two layers
of coating materials 18 and 19 constitute a housing, and we do not discern
any error in this finding.
Appellants also argue that Bhutani and Ibsen both teach away from
the use of a capsule. App. Br. 20; Reply Br. 20. This argument is not
convincing, because claim 1 does not require that the delivery device take
the form of a capsule. See In re Self, 671 F.2d 1344, 1348 (CCPA 1982)
(limitations not appearing in the claims cannot be relied upon for
patentability).
Appellants dispute the Examiner’s finding that Bhutani discloses
vehicles that comprise different active agents with different dosage
parameters combined into a single delivery device. App. Br. 18. The
Examiner correctly found that Bhutani describes including a mixture of
different pellets of different active agents in a single delivery device at
column 5, lines 58-68. See Ans. 13-14; Bhutani, col. 5, ll. 60-62. Further,
Bhutani describes a single delivery device comprising a mixture of different
pellets containing different drugs (active agents) and coated differently to
provide a controlled specific release rate for each medicament. Col. 5, ll.
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62-68. Thus, Bhutani discloses a delivery device comprising a plurality of
vehicles each “comprising a different combination and/or amount of an
active agent, . . . such that each of said vehicles comprises a different active
agent and/or release property from each other,” as called for in claim 1.
Appellants argue that Ibsen teaches combining two or more active
substances in the same composition, provided they are compatible. App. Br.
19, Reply Br. 19; see Ibsen, col. 7, ll. 1-3, 7-11. This argument is not
convincing because it is not commensurate with the scope of claim 1, which
does not require that the different active agents be incompatible with one
another. Further, in any event, Bhutani’s tablet, by virtue of the different
pellets each having a controlled specific release rate for each medicament
(col. 5, ll. 67-68), appears to be appropriately adapted to accommodate
different active agents regardless of their compatibility with one another.
Appellants also argue that it would not have been obvious to combine
Bhutani and Ibsen in the manner proposed by the Examiner because
“Bhutani is directed to a tablet formed from a compressed preselect shape of
pellets, whereas Ibsen is directed to a liquid suspension of particles.” App.
Br. 20; Reply Br. 20. Appellants’ argument does not apprise us of error in
the Examiner’s combination.
We fully appreciate that Bhutani and Ibsen disclose two different
approaches to drug delivery. Bhutani discloses dosage units for oral
administration in the form of “compressed tablets comprising mainly coated
pellets processed such that the tablets disintegrate rapidly in aqueous and
gastric fluids at body temperature.” Col. 1, ll. 11-14. Bhutani’s pellets are
specially coated (see col. 4, ll. 11-21) and then compressed into tablets or
pills (col. 4, ll. 21-22), such that when the tablet is subjected to water or
gastric fluid in the gastrointestinal tract, the tablet breaks up quickly
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releasing the individual pellets, which then act as independent pellets that
release their medicine (active agent) at a predetermined rate (col. 4, ll. 24-
29). Ibsen, on the other hand, discloses an oral composition that is “adapted
to be dispersed in an aqueous carrier substantially immediately prior to
administration.” Ibsen, Abstr.; col. 2, ll. 15-18. Ibsen’s composition
includes particles comprising an active substance and “a gelling or swelling
agent capable of forming a viscous medium around the particles in an
aqueous carrier.” Col. 2, ll. 18-22. The particles of active agent may be
admixed with the gelling or swelling agent in dry form, or the gelling or
swelling agent may be kept separately from the particles and dispersed in the
aqueous carrier to form the viscous medium prior to being admixed with the
particles. Col. 5, ll. 45-55. In another embodiment of the composition, “the
particles may be granulated together with the gelling or swelling agent.”
Col. 6, ll. 3-5. In yet another embodiment, the particles may be coated with
a coating including at least one layer comprising the gelling or swelling
agent. Col. 6, ll. 8-11.
Despite the differences in the delivery approaches disclosed by
Bhutani and Ibsen, both Bhutani and Ibsen disclose coating the active agent-
containing medium with a gelling or swelling agent. See Bhutani, col. 6, ll.
49-51; col. 8, ll. 20-24; Ibsen, col. 2, ll. 18-22; col. 6, ll. 8-11. As such,
Ibsen’s teachings as to the constituents of or additives to the gelling agent
composition for ensuring the proper viscosity in the vicinity of the active
agent-containing medium reasonably appear to be pertinent to Bhutani’s
disintegrating or swelling agents, and Appellants have not persuasively
shown why this would not be the case.
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For the above reasons, we sustain the rejection of claim 1 and of
claims 3-6, 8-11, 13, 14, 18, 23, 25, 27, and 29-31, which fall with claim 1,
as unpatentable over Bhutani and Ibsen.
In contesting rejections (3)-(5), Appellants merely rely on the
unpersuasive arguments asserted against rejection (1) and add that Dunn,
Zentner, and Giannos do not overcome the asserted deficiencies in the
combination of Bhutani and Ibsen. App. Br. 23-24; Reply Br. 24-25.
Accordingly, we also sustain rejections (3)-(5).
Rejection (2)
In contesting this rejection, Appellants argue that Shaked’s binder,
described as being hydroxypropylmethylcellulose, is part of the granule
composition itself, not part of a housing. App. Br. 22 (citing para. [0108]
and claims 6 and 7 of Shaked). This argument appears to be directed to
claim 7, which requires the housing to be made of “a material selected from
the group consisting of . . . hydroxypropyl methyl cellulose . . . .”
Appellants’ argument is not convincing, because Shaked discloses
that the dosage form can be a tablet (para. [0129]) and that the dosage form
outer layer can be a film coating comprising a polymer such as
hydroxypropylmethylcellulose (para. [0139]). Thus, the Examiner’s
determination that it would have been obvious to modify Bhutani’s
controlled delivery device (i.e., tablet) to provide a housing (i.e., the outer
coating layers 18 and 19) of the tablet made of hydroxypropyl methyl
cellulose for providing controlling elements for appropriate drug release and
treatment (Ans. 7) has rational underpinnings, as both references are
concerned with controlled drug delivery devices.
Appellants also argue that the charcoal additive of Shaked is part of
the granule itself and not part of a housing. App. Br. 22 (citing para. [0174]
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of Shaked). Appellants do not specifically direct this argument to any claim
in particular. In any event, the argument is not convincing because it is not
commensurate with the scope of any of the claims rejected as unpatentable
over Bhutani, Ibsen, and Shaked. Claims 7, 12, 19-24, 26, 28, and 32 do not
require that the housing contain a charcoal additive. Accordingly, we
sustain the rejection of claims 7, 12, 19-24, 26, 28, and 32 as unpatentable
over Bhutani, Ibsen, and Shaked.
DECISION
The Examiner’s decision rejecting claims 1 and 3-32 is sustained.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED

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