Appeal No. 1996-1273
Application 07/956,003
generally, In re Oetiker, 977 F.2d 1443, 1447-48, 24 USPQ2d 1443, 1446-47 (Fed. Cir. 1992)
(Nies, J., concurring).
The appealed claims, as represented by claim 25, are drawn to a complex, for oral delivery of7
a substance to the circulation or lymphatic drainage system of a host, that comprises at least a
microparticle coupled by covalent bond, hydrophobic interaction or both to a carrier which is Vitamin
B or a Vitamin B -analogue that binds Castle’s intrinsic factor. The microparticle is specified to be a12 12
microsphere or microcapsule that entraps or encapsulates the substance, maintains the substance
deleteriously unaffected by intestinal digestive substances and releases the substance into the circulation
or lymph. The carrier Vitamin B or a Vitamin B -analogue that binds Castle’s intrinsic factor is12 12
specified to be effective to transport the complex into the circulation or lymphatic drainage system of a
host via the intestinal mucosal epithelium. Upon comparing the claimed invention with the prior art, the
examiner applied essentially two different sets of prior art in rejecting the appealed claims. The first set
consists of Ranney, Papahadjopoulos, Geho and Guo which the examiner characterizes as teaching the
“concept of attaching various target molecules specific for tissues where the drug delivery is desired to
microspheres” but not “vitamin B as the targeting molecule” (answer, pages 5-6). The second set
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consists of Russell-Jones which is characterized by the examiner as teaching the “instant concept of
delivering a drug by complexing it with the carrier, B ” that is “administered orally and the purpose is to
12
deliver the drug in the intestines where B binds to the intrinsic factor” but not the “use of
12
microspheres” (answer, page 6).
Thus, the examiner submits two alternative positions in the rejection (answer, page 6) which are
essentially the same, that is, it would have been obvious to one of ordinary skill in this art to modify the
drug delivery system of Russell-Jones by coupling the “microspheres containing the drug to B ” rather
12
than the “drug itself . . . since encapsulation of drugs in microspheres results in their sustained release in
the intestines” as shown by Ranney, Papahadjopoulos, Geho and Guo. In this respect, the examiner
7We decide this appeal on claim 25 because, as noted by the examiner (answer, page 2), appellants
have not stated that the appealed claims do not stand or fall together. 37 CFR § 1.192(c)(7)
(1995).
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