Ex Parte Rinker et al

Board of Patent Appeals and Interferences

Mar 16, 2010

10756528 (B.P.A.I. Mar. 16, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte
ROGER A. RINKER, NICHOLAS J. CASALE, JAMES H. COMLY,
BRENDA POLLOCK, ATUL AYER, JOHAN GEERKE,
MARTIN COSTELLO, DENNIS WIEAND,
and KISHOR PAREKH
__________

Appeal 2009-012823
Application 10/756,528
Technology Center 1600
__________

Decided: March 16, 2010
__________

Before TONI R. SCHEINER, MELANIE L. McCOLLUM, and
STEPHEN WALSH, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 1-10 and 25-28, directed to a dosage form for delivery of an active
ingredient. The claims have been rejected on the ground of obviousness.
We have jurisdiction under 35 U.S.C. § 6(b).
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STATEMENT OF THE CASE
The claimed invention is directed to a dosage form comprising a core
with a “discontinuous gel coating and modified subcoating [that] provide
improved dissolution and disintegration properties, but . . . do[ ] not
compromise swallowability of the dosage form” (Spec. ¶ 68).
Claims 1 and 25 are representative of the subject matter on appeal:
1. A dosage form comprising:
a) a core having an exterior surface and first and second ends;
b) a subcoating over portions of the exterior surface of the core;
c) a first gelatinous coating over at least part of the subcoating;
and
d) a second gelatinous coating over at least part of the
subcoating;
wherein the first and second gelatinous coatings are provided on said
first and second ends of the core;
wherein said first and second gelatinous coatings form a gap between
which the subcoating is exposed;
wherein at least one opening is provided through the subcoating to
expose the exterior surface of the core, and
wherein the one or more openings are provided only through the
subcoating.

25. A method for producing a dosage form comprising:
a) coating a compressed tablet having two opposing ends with a
subcoating material;
b) providing one end of the coated compressed tablet in a
gelatinous material;
c) providing a second end of the coated compressed tablet in a
gelatinous material; and
d) providing one or more openings in the dosage form that
expose the compressed tablet;
wherein the gelatinous coatings resulting from steps b) and c) form a
gap that exposes the coating of step a) and wherein the one or more openings
are provided only through the subcoating.

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Figures 1-3 of the Specification, reproduced below, illustrate a dosage
form encompassed by claim 1, in various stages of fabrication:

Figure 1 of the Specification depicts compressed core 10 of a dosage
form, with subcoating 22; Figure 2 depicts an intermediate dosage form with
gap 26 exposing subcoating 22, between the first and second gelatinous
coatings 24, 24; while Figure 3 shows the final dosage form, with openings
32 provided “only through subcoating 22.” (Spec. ¶¶ 8-10, 56, 63.)

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The Examiner rejected the claims as follows:
• Claims 1-6 and 25-28 under 35 U.S.C. § 103(a) as unpatentable over
Martini1 and Brehaut.2

• Claims 1-10 and 25-28 under 35 U.S.C. § 103(a) as unpatentable over
Martini, Clarke,3 and Brehaut.

We reverse both rejections.

OBVIOUSNESS: MARTINI and BREHAUT
The Examiner rejected claims 1-6 and 25-28 as unpatentable over
Martini and Brehaut.
Issue
Does the evidence of record support the Examiner’s conclusion that a
dosage form with a gap in an outer gelatinous coating which leaves an
exposed band of subcoating, so that openings to the core of the dosage form
pass only through the subcoating, would have been obvious, given the
teachings of Martini and Brehaut?
Findings of Fact
FF1 Martini discloses an oral delivery device for a pharmaceutically
active agent comprising a core containing the active agent, and a multi-layer
outer coating “which includes one or more openings communicating from
the exterior of the device toward the core” (Martini ¶¶ 4, 16).

1 US 2004/0062806 A1, published April 1, 2004.
2 US 6,126,987, issued October 3, 2000.
3 WO 03/020246 A1, published March 13, 2003.
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FF2 “[T]he term ‘opening’ is . . . synonymous with orifice, hole,
passageway, aperture etc.” (Martini ¶ 18).
FF3 The openings in Martini’s device are “formed by removal of
one or more sections of outer coating” and “may pass all the way through
the coating, i.e., providing open communication from the exterior
environment of the device to the core” or “may disrupt only the outer
coating material (whether single or multi-layer)” (Martini ¶¶ 18, 19).
FF4 Martini does not disclose any device in which openings are
formed in a sublayer without also being formed in the outer coating - in
other words, Martini does not disclose a device in which “openings are
provided only through the subcoating,” as required by independent claims 1
and 25.
FF5 Brehaut teaches that compressed caplets and tablets can be
perceived as difficult to swallow because of the “chalky” texture of the
compressed mixture. “Research also has found, however, that people
believe that medicaments having a gelatin or similar coating are significantly
easier to swallow.” (Brehaut, col. 1, ll. 27-35.)
FF6 Brehaut discloses a method of coating a caplet with gelatin by
dipping a first portion (approximately half) of the caplet in a first gelatin
bath, and a second portion (approximately half) of the caplet in a second
gelatin bath, which may be a different color than the first (Brehaut, col. 19,
ll. 56-61).
The extent of dipping of each “half” can be controlled to
achieve coverage which extends from no overlap between the
first and second coating, to some overlap which is not visible to
the eye and may not be felt, to a substantial overlap which
provides a surface discontinuity which can be felt and/or seen.
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. . . [T]he first and second dipping profiles can be selected to
obtain the desired coating, ranging from no overlap, abutting
coatings, and overlapped coatings.

(Id. at col. 19, ll. 62 to col. 20, ll. 3.)

Principles of Law
Analyzing obviousness under 35 U.S.C. § 103 requires “a searching
comparison of the claimed invention - including all its limitations - with the
teaching of the prior art.” In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995).
“[A]ny need or problem known in the field of endeavor at the time of
invention and addressed by the patent can provide a reason for combining
the elements in the manner claimed.” KSR Int’l Co. v. Teleflex Inc., 550 U.S.
398, 420 (2007). However, “[w]e must still be careful not to allow hindsight
reconstruction of references to reach the claimed invention without any
explanation as to how or why the references would be combined to produce
the claimed invention.” Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363,
1374 n.3 (Fed. Cir. 2008).
Analysis
Appellants contend that the dosage form of claim 1 has a core, where
a portion of the exterior surface of the core is covered with a subcoating, a
first gelatinous coating covers the subcoating on one end of the dosage form,
and a second gelatinous coating covers the subcoating on the second end of
the dosage form, “such that the first and second gelatinous coatings form a
gap between which the subcoating is exposed” (App. Br. 2). The dosage
form has “openings in the form of holes” that expose the exterior surface of
the core, which “are provided only through the subcoating. In other words,
the openings are found only in the gap region that exposes the subcoating
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between the two [gelatinous] coatings” (id.). Appellants contend that claim
25 is directed to a method of producing a dosage form wherein “openings
are found only in the gap region that exposes the subcoating between the two
coatings” (id.).
The Examiner finds that Martini discloses an oral delivery device
comprising a tablet core covered with a multilayer coating that meets all the
limitations of the claims, except that “Martini fails to specifically identify
that the outer layer coating of the multilayer coat is gelatin” (Ans. 5).
However, the Examiner concludes that it would have been obvious “to
utilize gelatin as the outer coating in the tablet taught by Martini, which
features a multilayer coating with a core exposed by openings in the coatings
. . . because Brehaut teaches that gelatin is commonly used for coating
caplets and tablets” (id. at 6).
Appellants contend that combining the teachings of Marini and
Brehaut wouldn’t result in a dosage form with a gap in an outer gelatinous
coating which leaves an exposed band of subcoating, so that openings to the
core of the dosage form pass only through the subcoating, because “Martini
does not contemplate providing only partial coating layers or putting
openings only through underlying subcoatings”(App. Br. 3), and Brehaut
doesn’t describe “short-dipping” the first and second gelatin coatings to
leave a gap between them to expose a subcoating (id. at 4).
The Examiner’s response to Appellants’ argument is two-fold. First,
the Examiner argues that Martini’s “openings in a multilayer coating to
expose a core is readable upon the instant claims” (Ans. 10), because the
claims “do not require that the gap between the first and second gelatinous
coatings and the openings in the subcoating are necessarily different in size
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and/or position” (id.). Second, the Examiner argues that Brehaut’s “gelatin
dipping process can be practiced such that the extent of dipping two ends of
a caplet can be controlled to achieve no overlap between the first and second
coatings . . . which would result in a gap around the circumference of the
tablet near its midpoint” (id. at 6).
We disagree with the Examiner on both counts. Independent claims 1
and 25 specify that the “openings are provided only through the subcoating.”
If, as the Examiner proposes, the “gap” between the first and second
gelatinous coatings and the “openings” in the subcoating are identical in size
and position, the Examiner has not explained how it would be possible to
provide openings exposing the exterior of the core “only through the
subcoating.” In any case, the openings (i.e., apertures, holes) in Martini’s
device are provided by removing sections of outer coating, and may or may
not breech the subcoating at all (FF3). Moreover, Brehaut discloses both
“no-overlap, abutting coatings” and overlapping coatings (FF6), but doesn’t
disclose “short-dipping” to leave a gap between the coatings. Even if we
accept the Examiner’s assertion that Brehaut’s process could be modified to
leave a gap between first and second gelatinous coatings, the Examiner has
not provided any reason why one of ordinary skill in the art would do so.
Conclusions of Law
The evidence of record does not support the Examiner’s conclusion
that a dosage form with a gap in an outer gelatinous coating which leaves an
exposed band of subcoating, so that openings to the core of the dosage form
pass only through the subcoating, would have been obvious over Martini and
Brehaut.

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OBVIOUSNESS: MARTINI, CLARKE, and BREHAUT
The Examiner rejected claims 1-10 and 25-28 as unpatentable over
Martini, Clarke and Brehaut.
Issue
Does the evidence of record support the Examiner’s conclusion that a
dosage form with a gap in an outer gelatinous coating which leaves an
exposed band of subcoating, so that openings to the core of the dosage form
pass only through the subcoating would have been obvious, given the
teachings of Martini, Clarke and Brehaut?
Findings of Fact
FF7 Clarke discloses a pharmaceutical “delivery device comprising
a core . . . covered by an outer coating which includes one or more openings
communicating from the exterior of the device to the core characterised in
that the outer coating is applied by injection moulding said coating around
said core” (Clarke 1: 33-36).
Analysis
Clarke is similar to Martini in that openings are formed in the outer
coating of the delivery device, and does nothing to remedy the underlying
deficiency in the Examiner’s proposed combination of Martini and Brehaut.
Conclusions of Law
The evidence of record does not support the Examiner’s conclusion
that a dosage form with a gap in an outer gelatinous coating which leaves an
exposed band of subcoating, so that openings to the core of the dosage form
pass only through the subcoating would have been obvious, given the
teachings of Martini, Clarke, and Brehaut.

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SUMMARY
• The rejection of claims 1-6 and 25-28 under 35 U.S.C. § 103(a) as
unpatentable over Martini and Brehaut is reversed.

• The rejection of claims 1-10 and 25-28 under 35 U.S.C. § 103(a) as
unpatentable over Martini, Clarke, and Brehaut is reversed.

REVERSED

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PHILIP S. JOHNSON
JOHNSON & JOHNSON
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