Ex Parte Colombo et al

Board of Patent Appeals and Interferences

Jan 3, 2012

10496327 (B.P.A.I. Jan. 3, 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.
10/496,327 05/21/2004 Paolo Colombo COLOMBO, ET AL.-2
(PCT)
7550
25889 7590 01/03/2012
COLLARD & ROE, P.C.
1077 NORTHERN BOULEVARD
ROSLYN, NY 11576
EXAMINER
AHMED, HASAN SYED
ART UNIT PAPER NUMBER
1615
MAIL DATE DELIVERY MODE
01/03/2012 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 PAOLO COLOMBO, RUGGERO BETTINI, PATRIZIA SANTI,
and PIER LUIGI CATELLANI
__________

Appeal 2011-007514
Application 10/496,327
Technology Center 1600
__________

Before TONI R. SCHEINER, DEMETRA J. MILLS, and ERIC GRIMES,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a module
for controlled drug release. The Examiner has rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
The Specification discloses a “pharmaceutical form for controlled
drug release … obtained by the assembly of individual release modules, of
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which the capacity to release the drug in time and in space depends on the
way in which the modules have been assembled” (Spec. 1: 4-7).
Claims 36-39 are on appeal. Claims 37-39 have not been argued
separately and therefore stand or fall with claim 36. 37 C.F.R.
§ 41.37(c)(1)(vii). Claim 36 reads as follows:
36. A module for controlled drug release in the gastrointestinal tract,
composed of a matrix of biocompatible polymers comprising an active
principle and excipients, said module having one of the following shapes:
a cylindrical shape wherein one base of the cylinder is concave and
the other convex, wherein said concave base is jointly fittable by stacking on
said convex base; or
a polyhedric shape, wherein at least one of the faces of the polyhedron
is concave and at least one other of the faces of the polyhedron is convex,
wherein said at least one concave face is jointly fittable by stacking on said
at least one convex face.

Issue
The Examiner has rejected all of the claims under 35 U.S.C. § 103(a):
claims 36 and 37 in view of Colombo1 and Miyabe,2 claims 36-38 in view of
Colombo, Miyabe, and Omura,3 and claims 36, 37 and 39 in view of
Colombo, Miyabe and Friend.4 Since Appellants have waived any argument
based on Omura (Appeal Br. 12-13) or Friend (id. at 13-14), we will
consider the rejections together.
The Examiner finds that Colombo discloses a controlled release
pharmaceutical formulation comprising a matrix of biocompatible polymers,

1 Colombo et al., US 4,839,117, June 13, 1989
2 Miyabe et al., US 6,342,248 B1, Jan. 29, 2002
3 Omura US 6,303,144 B1, Oct. 16, 2001
4 Friend et al., US 6,139,865, Oct. 31, 2000
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an active principle, and excipients, and having a cylindrical shape (Answer
3). The Examiner finds that “Miyabe discloses a cylindrical tablet wherein
one base of the cylinder is concave and the other is convex” (id. at 4), and
that “[s]ince the concave and convex shapes are similarly curved, they are
inherently jointly fittable by stacking” (id.). The Examiner reasons that the
term “fittable” is read “in view of its broadest reasonable interpretation, as
applicants have not provided a special definition of the term in the
disclosure” (id.). The Examiner concludes that it would have been obvious
to a person of ordinary skill in the art to make “a cylindrical formulation,
wherein one base of the cylinder is concave and the other is convex,
comprising a matrix of biocompatible polymers comprising an active
principle and excipients … for its mild function and reduced side effects, as
explained by Miyabe” (id. at 4-5).
Appellants contend that the cited references would not have made
obvious a module for “the controlled drug release in the gastrointestinal
tract” (Appeal Br. 7) or a cylindrical module in in which a concave base “is
jointly fittable by stacking” on a convex base (Appeal Br. 7-9).
The issues presented are: Does the evidence of record support the
Examiner’s conclusion that the cited references would have made obvious a
module for controlled drug release having the shape required by claim 36?
Findings of Fact
1. Colombo discloses a “system for the controlled-rate release of
active substances” that consists of: (a) a deposit-core comprising the active
substance, a water-swellable polymeric material, and a gellable polymeric
material, and (b) a support-platform applied to the deposit-core and
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consisting of a polymeric material insoluble in aqueous liquids (Colombo,
abstract).
2. Colombo discloses that that the deposit-core can also include
excipients such as mannitol and magnesium stearate (id. at col. 5, l. 60 to
col. 6, l. 8).
3. Colombo discloses that the system may be used to administer
pharmaceuticals (id. at col. 4, ll. 9-13).
4. Miyabe discloses a “tablet … [that] can be divided easily and
accurately” (Miyabe, abstract).
5. Figure 16c of Miyabe is shown below:

Figure 16c shows a side view of a dividable tablet (id. at col. 2, ll. 47-50).
6. In reference to Figure 16c, Miyabe discloses that “[t]o divide the
tablet Th into two, a pharmacist, patient or the like holds the two areas R1
and R2 directly with his fingers and divides it into two along the dividing
line Ld. Alternatively, the tablet Th can be divided into two by pressing it
down from above” (id. at col. 3, ll. 4-8).
7. The Specification does not define the term “jointly fittable by
stacking.”
8. The Specification discloses that “the concave base/face of a first
cylindrical/polyhedric module … is configured in such a way as to be able to
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accommodate a corresponding convex base/face of a second module … to
give an assembly between the two modules” (Spec. 5: 14-17).
9. The Specification discloses that “[p]referably, this joint [between
modules] is also sufficiently strong from a mechanical point of view to hold
the two modules together in conditions of use” (id. at 5: 19-21).
10. The Specification discloses that “even in cases where the
adhesive or mechanical properties of the polymers used are poor…, it is
always possible to reinforce the join between the modules by gluing or
welding” (id. at 9: 21-24).
Principles of Law
“[D]uring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the specification.” In re Hyatt, 211
F.3d 1367, 1372 (Fed. Cir. 2000).
“[W]hile it is true that claims are to be interpreted in light of the
specification and with a view to ascertaining the invention, it does not follow
that limitations from the specification may be read into the claims.” Sjolund
v. Musland, 847 F.2d 1573, 1581 (Fed. Cir. 1988).
Analysis
Claim 36 is directed to module for controlled drug release that is
composed of biocompatible polymers, an active principle, and excipients,
and has a defined shape, for example “a cylindrical shape wherein one base
of the cylinder is concave and the other convex, wherein the concave base is
jointly fittable by stacking on the convex base.”
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Colombo discloses a controlled-rate release pharmaceutical dosage
form that comprises an active principle, biocompatible polymers, and
optional excipients. Miyabe discloses a cylindrical dosage form for
pharmaceuticals that is easily dividable and that comprises one convex base
and one concave base. In view of these disclosures, it would have been
obvious to one of skill in the art to form the controlled-rate release
pharmaceutical dosage form of Colombo into a cylindrical shape with one
convex face and one concave face, as disclosed by Miyabe, because Miyabe
discloses that such a shape provides the benefit of being easily dividable.
Appellants argue that the cited references would not have made
obvious a module for “the controlled drug release in the gastrointestinal
tract” because the references are not directed to compositions for the
controlled drug release in the gastrointestinal tract (Appeal Br. 7). This
argument is not persuasive because Colombo discloses tablet-shaped dosage
forms for administration to a patient, and expressly discloses that its dosage
form is particularly designed for controlled-rate release when in contact with
aqueous liquids. Thus, a module or dosage form for “the controlled drug
release in the gastrointestinal tract” would have been obvious in view of the
cited references.
Appellants argue that the cited references would not have made
obvious a cylindrical module in which the concave base “is jointly fittable
by stacking” on the convex base (Appeal Br. 7-9). Appellants argue that
Miyabe does not disclose a dosage form that meets this limitation and that
“the skilled person in the art is well aware of the meaning of the term
‘fittable’ by the definition of ‘module’” in the Specification (id. at 7). Thus,
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Appellants argue that one of skill in the art would recognize that a module is
“joinable with a second module for construing [sic] systems, such as the one
represented in Figure 4 of the pending application, since ‘the joint is
sufficiently strong from a mechanical point of view to hold the two modules
together in conditions of use’” (id. at 8, quoting Spec. 5: 19-21). Appellants
argue that “[t]his means that, when more than one module is needed, the
module itself has been designed to be sufficiently resistant to bear the
exerted mechanical pressure without breaking” (Appeal Br. 9).
As we understand it, Appellants’ argument is that the “jointly fittable
by stacking” limitation of claim 36 requires a precise fit between the convex
base and concave base, so that two modules will hold together when stacked
and pressed together, and that Miyabe’s dosage form does not show a
precise fit between the convex base and the concave base. This argument is
not persuasive.
In accordance with In re Hyatt, claim terms are given their broadest
reasonable interpretation consistent with the specification. Here, the
Specification states that “the concave base … is configured in such a way as
to be able to accommodate a corresponding convex base … to give an
assembly between the two modules” (FF 8). The Specification also states
that “[p]referably, this joint is … sufficiently strong from a mechanical point
of view to hold the two modules together” (FF 9, emphasis added). The
Specification also states that “it is always possible to reinforce the join
between the modules by gluing or welding” (FF 10). Thus, the broadest
reasonable interpretation of the term “jointly fittable by stacking” requires
that the concave base be configured to accommodate the convex base, but
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does not require a precise fit between the concave base and the convex base,
since that is merely a preferred embodiment. We agree with the Examiner
that the broadest reasonable interpretation of the claim language reads on the
shape of Miyabe’s dosage form, because it has a concave base that is
configured in such a way that it could accommodate the convex base.
Appellants further argue that Miyabe’s tablets are “not designed to be
potentially jointed together so as to form a compound system, but … are
designed to be divided into two” (Appeal Br. 10).
This argument is not persuasive because, even if Miyabe’s tablets are
designed to be divided rather than stacked, they have the shape defined by
claim 36. Thus, the cited references considered together would have made
obvious a product meeting all of the structural limitations of claim 36. Cf.
Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed.
Cir. 2002) (“[T]he patentability of apparatus or composition claims depends
on the claimed structure, not on the use or purpose of that structure.”).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
cited references would have made obvious a module for controlled drug
release having the shape required by claim 36.
SUMMARY
We affirm the rejection of claims 36-39 under 35 U.S.C. § 103(a).
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Application 10/496,327

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TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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