Appeal No. 1999-1229
Application 08/543,975
and enable release only in the duodenum. Id., col. 2, lines 43-58. Although never
mentioned by the examiner, we note that Sipos discloses that lactases from microbial
sources are suitable enzymes which can be formulated into an enterically-coated
composition. Id., col. 5, lines 35-37.
According to the examiner [Answer, pp. 5-6]:
Clearly, the prior art motivates one of ordinary skill in the art to formulate a lactase
enzyme in the treatment of lactose intolerance and to facilitate the hydrolysis of lactose in
mammals. The claims differ from the teachings of Barillas, Medow and Rosado in that
none of the references teach the combination of the two lactases together in a solid, orally
administrable formulation. However, in view of the teaching of the prior art taken as a
whole, the practitioner would reasonably expect that a “superior processing effect” (per the
teaching of Kan) would be obtained in vivo as well as in vitro by administering both
enzymes together as the prior art acknowledges that one of ordinary skill in the art is well
aware of the teachings of Rosado which show that either enzyme is individually effective
when administered alone. Therefore, it would have been obvious per the disclosure of Kan
et al. to optimize the degree of lactose hydrolysis by the administration of two different
lactase enzymes having different optimum pH ranges for the purpose of maximizing the
amount of lactase hydrolysis as the lactase travels from the stomach and the intestine.
Each lactase enzyme is well known for both its activity and optimum pH range.
It is well established that the examiner has the initial burden under § 103 to establish
a prima facie case of obviousness. In re Oetiker, 977 F.2d 1443, 1445,
24 USPQ2d 1443, 1444 (Fed. Cir. 1992); In re Piasecki, 745 F.2d 1468, 1471-72,
223 USPQ 785, 787-88 (Fed. Cir. 1984). It is the examiner’s responsibility to show that
some objective teaching or suggestion in the applied prior art, or knowledge generally
available [in the art] would have led one of ordinary skill in the art to combine the references
to arrive at the claimed invention. Pro-Mold & Tool Co. v. Great Lakes Plastics, Inc., 745
6
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 Next
Last modified: November 3, 2007