Appeal No. 95-0815
Application 07/963,967
al.3 and of appealed claim 13 under 35 U.S.C § 103 over Theeuwes et al. as previously applied further
in view of American Hospital Formulary Services, as set forth in the answer (Paper No. 18, pages 3-4).
It is well settled that the examiner may satisfy his burden of establishing a prima facie case of
obviousness under § 103 by showing some objective teachings or suggestions in the prior art taken as a
whole or that knowledge generally available to one of ordinary skill in the art would have led that person
to arrive at the claimed invention as a whole, including each and every limitation of the claims, without
recourse to the teachings in appellants’ disclosure. See generally In re Fine, 837 F.2d 1071, 1074-
76, 5 USPQ2d 1596, 1598-1600 (Fed. Cir. 1988); In re Dow Chem. Co., 837 F.2d 469, 473, 5
USPQ2d 1529, 1531-32 (Fed. Cir. 1988); In re Warner, 379 F.2d 1011, 1014-17, 154 USPQ 173,
176-78 (CCPA 1967), cert. denied, 389 U.S. 1057 (1968). We cannot conclude that the
examiner has carried her burden in the case before us.
We agree with appellants (main brief, Paper No. 14, page 3) that Theeuwes et al. does not
teach a dosage form containing a drug composition which comprises at least a steroid, a hydrophilic
polymer possessing a critical solution temperature of 35° to 50°C, and a polyhydroxy compound that
exhibits an affinity for water as required in the method of appealed claim 11. Theeuwes et al. disclose a
dosage form which contains two separate compositions, i.e., a drug composition (“first component 16;”
e.g. col. 4, lines 14-31, and col. 6, line 23, to col. 7, line 5) and a push composition (“second
component 17;” e.g., col. 4, lines 32-56, and col. 7, lines 66), in similar manner to the dosage form of
appealed claim 11. However, the drug composition as taught in the reference does not contain the
hydrophilic polymer and the polyhydroxy compound specified in the appealed claims. Indeed, this is
apparent from the examiner’s reliance on portions of the reference disclosure which pertain to the push
composition to find these components, and in fact, the portion of appellants’ specification relied on by
the examiner for a description of the hydrophilic polymer is directed to the push composition found in
the appealed claims (answer, page 3). We further note that Theeuwes et al. (col. 8, lines 31-50)
separately prepare and compress the drug and push compositions and the examiner has not set forth
2 Amendment of May 28, 1993 (Paper No. 4, pages 2-3).
3 The references relied on by the examiner are listed at page 2 of the answer. We refer to these
references in our opinion by the name associated therewith by the examiner.
- 2 -
Page: Previous 1 2 3 4 Next
Last modified: November 3, 2007