Ex Parte Neuer et al

Board of Patent Appeals and Interferences

Nov 10, 2003

09738212 (B.P.A.I. Nov. 10, 2003)

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The opinion in support of the decision being entered today
was not written for publication and is not binding precedent
of the Board.
Paper No. 18
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte KLAUS NEUER,
MONIKA PETSZULAT and HATTO WALCH
__________
Appeal No. 2003-1422
Application 09/738,212
__________
ON BRIEF
__________
Before WILLIAM SMITH, GRIMES, and POTEATE, Administrative Patent
Judges.
POTEATE, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final
rejection of claims 21-30 and 33. Claims 31 and 32 are also
pending, but have been withdrawn from consideration as directed
to a non-elected invention. Claims 21 and 33 are representative
of the subject matter on appeal and are reproduced below:
Appeal No. 2003-1422
Application 09/738,212

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21. A hard gelatin capsule comprising
(a) a cyclosporin as active ingredient,
(b) a polyethoxylated saturated hydroxy-fatty
acid, and
(c) a C2-C3 alcohol having one or two hydroxy
groups.
33. A hard gelatin capsule of claim 21 further
comprising
(d) mono-, di- and/or triesters of fatty acids,
and optionally
(e) ricinoleic acid glyceride(s) together with
smaller proportions of multiply unsaturated
fatty acid glycerides or caster oil
as a unit dosage form.

The references relied upon by the examiner are:
Orbán et al. (Orbán) 5,047,396 Sept. 10, 1991
Hauer et al. (Hauer) 5,342,625 Aug. 30, 1994
GROUNDS OF REJECTION
1. Claim 33 stands rejected under 35 U.S.C. § 112,
second paragraph, as being indefinite.
We affirm.
2. Claims 21-30 and 33 stand rejected under 35 U.S.C.
§ 103 as unpatentable over Orbán in view of Hauer.
We reverse.
3. Claims 21-30 and 33 stand provisionally rejected
under the judicially created doctrine of obviousness-type double
patenting as being unpatentable over claims 1-30 of copending
Application No. 09/690,400.
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Application 09/738,212

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We reverse.
4. Claims 21-30 and 33 stand provisionally rejected
under the judicially created doctrine of obviousness-type double
patenting as being unpatentable over claims 1 and 2 of copending
Application No. 09/605,512.
We vacate.
5. Claims 21-30 and 33 stand provisionally rejected
under the judicially created doctrine of obviousness-type double
patenting as being unpatentable over claims 1-3, 5-8, 15, 17, 19,
24, 26 and 28 of copending Application No. 09/547,802.
We affirm.
BACKGROUND
The invention relates to a hard gelatin capsule
comprising cyclosporin as the active ingredient, a poly-
ethoxylated saturated hydroxy-fatty acid and a C2-C3 alcohol.
Claim 21. Cyclosporins possess anti-inflammatory and anti-
parasitic activity and are used for a variety of applications
which include the treatment of inflammatory disorders and various
auto-immune diseases. Specification, page 1.
Cyclosporins have a strongly hydrophobic character and
are difficult to process with the usual pharmaceutical excipients
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to form preparations having sufficient bioavailability. Id.,
page 2. It is known to administer cyclosporin intravenously.
Id., page 3. However, a disadvantage of intravenous preparations
is that they must be administered in clinics by trained
personnel. Id. Oral preparations, though more easily
administered, suffer from the drawback of low and variable
bioavailability. Id., page 4. See Hauer, column 3, lines 57-61.
According to appellants, the claimed oral cyclosporin preparation
provides comparable bioavailability to intravenously
administrable preparations. Specification, page 7.
DISCUSSION
1. Rejection of claim 33 under 35 U.S.C. § 112,
second paragraph, as indefinite
According to the examiner, claim 33 is vague and
indefinite because it is unclear what appellants are claiming for
component (e). Examiner’s Answer, Paper No. 14, mailed
January 15, 2003, page 3. In particular, the examiner maintains
that it is unclear as to whether appellants are claiming a
combination of ricinoleic acid glycerides and multiply
unsaturated fatty acid glycerides, or castor oil, or whether
appellants are claiming a mixture of ricinoleic acid glycerides
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with multiply unsaturated fatty acid glycerides, or a mixture of
ricinoleic acid glycerides with castor oil. While appellants
attempt to explain what is intended by this language (see Appeal
Brief, Paper No. 13, received October 16, 2002, page 2), we are
in agreement with the examiner that the claim language is
indefinite. In fact, even upon reading appellants’ explanation
as to what is intended by this language, we are still unclear as
to what is being claimed. We are further in agreement with the
examiner that the language “smaller proportions of multiply
unsaturated fatty acid glycerides” is indefinite as it is unclear
what the basis for comparison is. See Examiner’s Answer, page 3.
2. Rejection of claims 21-30 and 33 under 35 U.S.C.
§ 103 as unpatentable over Orbán in view of Hauer
It is the examiner’s position that Orbán discloses the
cyclosporin composition of claim 21, but fails to teach that the
composition may be provided in a hard gelatin capsule. See
Examiner’s Answer, page 8. The examiner maintains that it would
have been obvious to one of ordinary skill in the art at the time
of the invention to have prepared Orbán’s composition in a hard
gelatin capsule in view of the teachings of Hauer. Id., page 5.
In particular, the examiner notes that Hauer is directed to
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1Appellants also note that one of the differences between
Hauer’s composition and that of the claimed invention is that the
present invention requires a polyethoxylated saturated hydroxy-
fatty acid component which is not taught by Hauer. Id.
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pharmaceutical compositions comprising cyclosporins which include
an alcohol and may contain a single surfactant, such as
polyoxyethylene stearic acid ester. Id., page 4. Hauer’s
composition may be provided in hard or soft gelatin capsules.
Id.
Appellants argue that Orbán’s disclosure is limited
to a cyclosporin containing composition for intravenous admin-
istration. Appeal Brief, page 3.1 According to appellants,
“[t]here is no teaching or suggestion that this composition may
also be advantageous with respect to stability and bioavail-
ability in medicaments for oral administration.” Id. While
appellants do not dispute the examiner’s finding that Hauer
discloses a cyclosporin-containing composition in a hard gelatin
capsule, they maintain that there would have been no motivation
to have combined the teachings of Orbán and Hauer since Orbán
fails to disclose or suggest that his composition may also be
used for oral administration. Appeal Brief, page 3.
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“[T]he question under 35 U.S.C. § 103 is not merely
what the references expressly teach, but what they would have
suggested to one of ordinary skill in the art at the time the
invention was made.” In re Lamberti, 545 F.2d 747, 750, 192 USPQ
278, 280 (CCPA 1976). In order to establish a prima facie case
of obviousness, the examiner must identify a suggestion or
motivation to modify the teachings of the cited references to
achieve the claimed invention. In re Kotzab, 217 F.3d 1365,
1370, 55 USPQ2d 1313, 1316-17 (Fed. Cir. 2000). The suggestion
or motivation to modify a reference may be implicit from the
prior art as a whole rather than expressly stated. Id. However,
regardless of whether the examiner relies on an express or
implicit showing, he must provide reasons for finding a
limitation to be taught or suggested in the reference. Id.
We are in agreement with appellants, that the examiner
has failed to satisfy his burden of identifying a suggestion or
motivation to modify the teaching of Orbán in view of Hauer to
achieve the claimed invention. In support of his proposed
combination, the examiner states that
[i]t would have been obvious to one of
ordinary skill in the art at the time of the
invention to prepare the composition of US
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‘396 in a hard gelatin capsule as taught by
US ‘625 with the reasonable expectation of
obtaining a cyclosporin composition that
provides convenient oral administration and
improved bioavailability. [Examiner’s Answer,
page 5.]
However, the examiner has failed to identify any support in the
references for this conclusion. In reviewing Orbán, we are in
agreement with appellants that the reference is clearly limited
to an intravenous pharmaceutical composition. See, e.g., Orbán,
column 2, lines 9-14 (“Therefore our aim was to work out an
intravenous pharmaceutical composition comprising cyclosporin as
active ingredient which is more tolerable than the known
intravenous formations, i.e., its anaphylactic-hypersenzibilizing
effect is smaller than that of the known formulation.”). By
contrast, Hauer is strictly limited to a cyclosporin containing
composition which is suitable for use in topical formulations
and, in particular, oral dosage forms. See Abstract.
Having found that the examiner has failed to establish
a prima facie case of obviousness, the rejection is reversed.
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3. Provisional rejection of claims 21-30 and 33
under the judicially created doctrine of obvious-
type double patenting as being unpatentable
over claims 1-30 of copending Application
No. 09/690,400
Application No. 09/690,400 issued as U.S. Patent
No. 6,258,808 on July 10, 2001. We have reviewed the claims of
the issued patent and have concluded that they are not directed
to the same invention claimed in present claims 21-30 and 33, and
do not render obvious claims 21-30 and 33.
The rejection is reversed.
4. Provisional rejection of claims 21-30 and 33
under the judicially created doctrine of obvious-
type double patenting as being unpatentable
over claims 1 and 2 of copending Application
No. 09/605,512
Application No. 09/605,512 was abandoned on
March 26, 2002. Accordingly, we vacate this ground of rejection.
5. Provisional rejection of claims 21-30 and 33
under the judicially created doctrine of obvious-
type double patenting as being unpatentable
over claims 1-3, 5-8, 15, 17, 19, 24, 26
and 28 of copending Application No. 09/547,802
Appellants fail to present arguments traversing this
ground of rejection. See Appeal Brief, page 4. Accordingly,
the rejection is affirmed.
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In sum, we affirm the rejection of claim 33 under
35 U.S.C. § 112, second paragraph, and affirm the provisional
obviousness-type double patenting rejection of claims 21-30 and
33 based on copending Application No. 09/547,802. We reverse the
provisional obviousness-type double patenting rejection based on
Application No. 09/690,400, now patented. We vacate the
provisional rejection of claims 21-30 and 33 under the judicially
created doctrine of obviousness-type double patenting as
unpatentable over claims 1 and 2 of Application No. 09/650,512,
now abandoned. We reverse the rejection of claims 21-30 and 33
under 35 U.S.C. § 103 as unpatentable over Orbán in view of
Hauer.
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TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in con-
nection with this appeal may be extended under 37 CFR § 1.136(a).
AFFIRMED
WILLIAM F. SMITH )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
ERIC GRIMES ) APPEALS AND
Administrative Patent Judge ) INTERFERENCES
)
)
)
LINDA R. POTEATE )
Administrative Patent Judge )
LRP:psb
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Thomas Hoxie
Novartis Corporation
Patent and Trademark Department
564 Morris Avenue
Summit, NJ 07901-1027