Ex Parte Dobler et al

Board of Patent Appeals and Interferences

May 21, 2010

10258006 (B.P.A.I. May. 21, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MONIKA DOBLER, STEFAN MERKLE, PEDRO LORCA,
and DIETER BACHMANN
__________

Appeal 2009-010873
Application 10/258,006
Technology Center 1600
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Decided: May 21, 2010
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Before CAROL A. SPIEGEL, DEMETRA J. MILLS, and
STEPHEN WALSH, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).

Appeal 2009-010873
Application 10/258,006

STATEMENT OF CASE
The following claim is representative.
1. A blister package for topiramate tablets comprising a pan sheet
having preformed cavities containing topiramate tablets wherein the pan
sheet is a sheet selected from the group consisting of a single metal layer,
multiple metal layers, and a composite metal and plastic layer, and a cover
sheet sealed to the pan sheet wherein the cover sheet is a sheet selected from
the group consisting of a single metal layer, multiple metal layers, a
composite metal and plastic layer, a composite metal and paper layer and a
composite metal, plastic and paper layer; wherein the topiramate tablets have
a free water content of between about 0.4% to about 1.4% at the time the
cover sheet is sealed to the pan sheet and wherein the blister package thus
formed contains no desiccant.

Cited References
Mitra et al. US 5,955,105 Sept. 21, 1999
Thakur et al. WO 99/44581 Sept. 10, 1999
Flöther et al. 0 779 872 B1 Jun. 25 1997

Grounds of Rejection
Claims 1 and 4-10 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Flöther in view of Thakur and Mitra.

FINDINGS OF FACT
1. The Examiner finds that
Flöther et al. ('872) teach a blister package providing
preparation cavities and drying agent cavities for packaging
moisture-sensitive solid or semi-solid pharmaceutical
preparations (see column 1, lines 5-10). The blister package is
preferably made of plastics and aluminum, which have cavities
for the uptake of the solid to be packaged in the pan sheet
(usually in the plastic sheet) and which are closed by sealing
with a second sheet, a so called cover sheet, preferably a coated
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aluminum foil, whereby the product at its offtake can be pushed
through the cover sheet by pressure on the pan sheet (col. 2,
lines 11-18).

(Ans. 4.)
2. “According to Flöther et al. a problem of the present invention is to
provide a blister package for the dry storage of pharmaceutical preparations,
for which the accidental intake of the drying agent is prevented (col. 3, lines
5-8).” (Id.)
3. The Examiner finds that
The inventive blister package [of Flöther] has a pan sheet (4)
with cavities (1) for the uptake of effective substance-
comprising preparations and cavities (2) for the uptake of
drying agents as well as a cover sheet (5) sealed to said pan
sheet (4), characterized in that the blister package in the region
of the drying agent cavities (2) is reinforced thus, that the
withdrawing of a drying agent carried by said drying agent
cavity (2) with usual finger pressure is prevented, and that the
reinforcement over the drying agent cavities (2) cannot be
removed by applying usual means (col. 4, lines 3-19).

(Id.)
4. Thakur teaches that there is no need for a dessicant to stabilize a solid
formulation of topiramate, which is a sprinkle formulation of topiramate.
The sprinkles contain more than 10% moisture by weight and this moisture
does not accelerate the degradation of topiramate. (Thakur, 17.)
5. Thakur discloses a coated solid dosage formulation of topiramate.
(Thakur, 5.)
6. Thakur discloses that the total drying time required to insure the water
content has been reduced to the desired level may take much longer,
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depending on the temperature and the size of the batch. (Thakur, page. 11,
ll. 26-28; page 12, 11. 20-23.)
7. Thakur discloses that coated granules may be compressed into tablets.
(paragraph bridging pages 6-7.)
8. According to the Specification, page 7, ll. 10-13, “free water” content is
unbound water. The total water content includes both crystalline bound
water and free water. The free water content can be calculated by
subtracting the bound water from the total water content. Thus total water
content is generally more than free water content.

Discussion
ISSUE
The Examiner finds the claimed subject matter is obvious over Flöther
in view of Thakur and Mitra, and that the cited references disclose or
suggest a solid formulation of topiramate with the claimed free water content
and a blister package of topiramate without the use of a dessicant.
Appellants contend that the cited references do not disclose or suggest
the claimed free water content of topiramate, or that it is possible to package
topiramate tablets in a blister pack without the use of a dessicant, as claimed.
The issue is: Does the cited evidence support the Examiner’s
conclusion that the cited references disclose or suggested the claimed free
water content of topiramate and that it is possible to package topiramate in a
blister pack without the use of a dessicant, as claimed?

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PRINCIPLES OF LAW
“[T]here must be some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness.” In re Kahn,
441 F.3d 977, 988 (Fed. Cir. 2006).

ANALYSIS
The Examiner finds the claimed invention is obvious over Flöther in
view of Thakur and Mitra.
The Examiner notes that the instant claims require no desiccant.
(Ans. 5.) Flother et al. teach the inclusion of a drying agent or desiccant.
(Ans. 5.) However, the Examiner argues that the inclusion of a desiccant as
taught by the art would not be deemed a detrimental component, since the
art clearly teaches that the drying agent cannot be accessed using usual
application means, such as by applying normal pressure. (Ans. 5.)
Thakur describes that moisture accelerates the degradation of
topiramate and that there is no need for a dessicant when Thakur’s
solid pharmaceutical formulation of topiramate which is a sprinkle
formulation.
We do not find that the Examiner’s analysis and rationale supports the
rejection of the claimed blister pack of topiramate without a dessicant. We
reverse this rejection. We do not find that the Examiner has provided a
rationale to support an obviousness rejection wherein the blister pack of
topiramate requires no dessicant, and a specific free water content of the
drug. We do not find that the Examiner’s indication in the Answer that the
inclusion of a desiccant as taught by the art would not be deemed a
detrimental component (Ans. 5), is a legally sufficient teaching of a blister
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pack with no dessicant. As to the free water content of topiramate, we do
not find that a free water content of thyroid hormone and in Mitra, informs
one of ordinary skill in the art as to acceptable levels of free water content
for an entirely different drug, topiramate.

CONCLUSION OF LAW
The Examiner’s rationale does not support a conclusion that the cited
references disclose or suggest the claimed topiramate free water content or
blister pack without a dessicant.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

REVERSED

cdc

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