Ex parte GODDARD et al.

Board of Patent Appeals and Interferences

Feb 23, 1998

08115836 (B.P.A.I. Feb. 23, 1998)

Application for patent filed September 3, 1993. 1
According to appellants, this application is a continuation of
Application 07/963,939, filed October 20, 1992; which is a
continuation of Application 07/734,910, filed July 24, 1991;
which is a continuation-in-part of Application 07/615,348, filed
November 19, 1990, all abandoned.
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THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered
today (1) was not written for publication in a law
journal and (2) is not binding precedent of the Board.
Paper No. 12
UNITED STATES PATENT AND TRADEMARK OFFICE
________________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
________________
Ex parte LLOYD E. GODDARD and GEORGE A. KNESEL
________________
Appeal No. 95-1820
Application 08/115,8361
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ON BRIEF
________________
Before KIMLIN, WEIFFENBACH and PAK, Administrative Patent Judges.
KIMLIN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal from the final rejection of claims 1 and
15, all the claims remaining in the present application. Claims
1 and 15 are reproduced below:
1. A process for preparing crystalline ibuprofen having a
crystal habit characterized by having a particle length larger
Appeal No. 95-1820
Application 08/115,836
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than 150 microns average and a length to width aspect ratio of
from about 4 to 1 to about 5 to 1 comprising
(a) forming a saturated solution of ibuprofen in a
liquid hydrocarbon solvent at a temperature from about 20EC to
about 60EC;
(b) seeding said saturated solution with solid
ibuprofen;
(c) cooling said saturated solution to a temperature of
about 0EC to about -20EC at a rate to retard primary nucleation
and promote secondary nucleation to obtain a slurry; and
(d) separating the crystalline ibuprofen from the liquid
phase of the slurry.
15. Crystalline ibuprofen having a crystal habit
characterized by having a particle length larger than 150 microns
average and a length-to-width aspect ratio of from about 4.1 to 1
to about 5 to 1.
The examiner relies upon the following reference as evidence
of obviousness:
Gordon et al. (Gordon) 4,476,248 Oct. 9, 1984
Appellants' claimed invention is directed to crystalline
ibuprofen having a specific crystal habit, and a process for
preparing the crystalline ibuprofen. The crystalline ibuprofen
of the present invention has an average particle length greater
than 150 microns and a length to width aspect ratio of from about
4 to 1 to about 5 to 1. The process entails seeding a saturated
solution of ibuprofen in a liquid hydrocarbon solvent followed by
cooling the saturated solution at a rate which retards primary
nucleation and promotes secondary nucleation. According to the
Appeal No. 95-1820
Application 08/115,836
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present specification, primary nucleation is defined as
spontaneous whereas secondary nucleation is induced by the
addition of crystal nuclei. We are told that, compared to
crystalline ibuprofen of the prior art, the crystalline ibuprofen
of the present invention flows more evenly through high volume
processing equipment and compacts more readily into tablets or
capsules.
Claims 1 and 15 stand rejected under 35 U.S.C. § 103 as
being unpatentable over Gordon.
Upon careful consideration of the opposing arguments
presented on appeal, we concur with appellants that the applied
Gordon reference fails to establish a prima facie case of
obviousness for the claimed subject matter. Accordingly, we will
not sustain the examiner's rejections.
We consider first the examiner's rejection of claim 1.
Although the examiner recognizes that Gordon does not teach the
claimed process steps of crystallization, the examiner reasons
that because the claimed "steps of seeding, cooling and
separation are inherently known to be a part of a crystallization
process, [it] would have been easily obvious to one of most basic
skill in the art" to perform the claimed process (page 2 of
Answer). However, the flaw in the examiner's reasoning is that
the claimed process requires preparing crystalline ibuprofen
Appeal No. 95-1820
Application 08/115,836
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having an average particle length larger than 150 microns by
cooling a saturated solution of ibuprofen at a particular rate,
and the examiner has not cited any prior art which teaches or
suggests that crystalline ibuprofen of the claimed particle size
can be made by any process. The prior art discussed by Gordon,
which is relied upon by the examiner, evidences that it was
generally known that crystallization procedures produce particle
size of 40 microns. Gordon claims a particle size larger than 18
microns (see claim 17), and EXAMPLE 4 of the reference describes
the largest average particle size as 82.6 microns. Hence,
although the general crystallization procedure is within the
prior art, there is no evidence of record which establishes that
the particular crystallization technique detailed in appellants'
specification for preparing crystalline ibuprofen having an
average particle size larger than 150 microns was obvious to one
of ordinary skill in the art.
We now turn to the examiner's rejection of claim 15 under
§ 103 over Gordon. It is the examiner's position that since
Gordon discloses crystalline ibuprofen having a particle size
range greater than 18 microns, the disclosure of Gordon
"encompasses the particle size range of the claimed invention"
(sentence bridging pages 3 and 4 of Answer). However, it is now
well settled that a prior art disclosure of a potentially
Appeal No. 95-1820
Application 08/115,836
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infinite genus does not necessitate a finding of obviousness for
a claimed feature that falls within the genus. In re Baird, 16
F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994); In re
Jones, 958 F.2d 347, 350, 21 USPQ2d 1941, 1943 (Fed. Cir. 1992).
In the present case, we do not find that Gordon's disclosure of a
virtually infinite genus of "an average particle size larger than
18 µ," and exemplification of 82.6 as the largest average
particle size, support a conclusion of obviousness for the
claimed crystalline ibuprofen having an average particle size of
larger than 150 microns.
In conclusion, based on the foregoing, the examiner's
decision rejecting the appealed claims is reversed.
REVERSED
EDWARD C. KIMLIN )
Administrative Patent Judge )
)
)
)
)
CAMERON WEIFFENBACH ) BOARD OF PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
)
)
)
CHUNG K. PAK )
Administrative Patent Judge )
Philip M. Pippenger
Appeal No. 95-1820
Application 08/115,836
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Albemarle Corp.
451 Florida St.
Baton Rouge, LA 70801-1780