Appeal No. 2001-1101 Page 8
Application No. 08/932,834
substantial indications of therapeutic efficacy." Accordingly, the premise of the
examiner's rejection is incorrect and the rejection cannot be sustained.
Further, the examiner argues that applicants' specification does not provide
useful daily dosage information (Paper No. 43, page 10, last full paragraph; and
paragraph bridging pages 10 and 11). We would agree that there is room for
improvement in applicants' description of a dosage regimen at page 9, first full
paragraph of the specification. That passage, standing alone, is somewhat unclear.
This does not, however, end the inquiry. Rather, the specification must be considered
in its entirety taking into account the level of skill in the art. The following passage
appears in the specification, page 9, second full paragraph:
While dosage values will vary, therapeutic compounds of the invention
may be administered to a human subject requiring such treatment as an
effective oral dose of about 50 mg to about 5000 mg per day, depending
upon the weight of the patient. For any particular subject, specific dosage
regimens should be adjusted to the individual's need and to the
professional judgment of the person administering or supervising the
administration of the inventive compounds.
In our judgment, the above-quoted passage adequately conveys to any person skilled
in the art useful daily dosage information for the claimed compounds.
The examiner's rejection of claim 14 under 35 U.S.C. § 112, first paragraph, is
reversed.
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