Appeal No. 2001-1909 Page 4
Application No. 09/016,786
continuous 24-hour basis, a therapeutically effective amount of at least
one pharmaceutically-acceptable B complex Vitamin.”
The third aspect of the invention relates to the subject matter of the claims on
appeal.
The specification (page 10, lines 11-233) states that the third aspect of the
invention, by which at least one vitamin B complex is administered to a human
on a substantially continuous 24-hour basis, “optimizes the natural nerve repair
process which occurs during sleep.” The substantially continuous 24-hour
administration may be achieved by either
· “multiple dosages during the daytime and at night,” (p. 7, lines 15-16); or,
· “administering … a controlled release dosage” (p. 7, line 21) which
o “may be administered about once every 24 hours” (p. 7, line 24),
i.e., a 24-hour controlled release dosage form; or
o “twice every 24 hours,” (p. 7, line 27), i.e., a 12-hour controlled
release dosage form.
“Determination of the proper dosage for a particular situation is within the skill of
the art. For convenience, the total daily dosage may be divided and administered
in portions during the day if desired or at one time, morning, afternoon, night … .”
Specification, p. 14, lines 28-32.
The application was originally filed with 49 claims.4 A preliminary
amendment was filed canceling the original claims and adding claims 50-61.
3 The B complex Vitamins have been identified as major elements involved in the repair
and maintenance of the nervous system. It has been noted that significant nerve tissue repair
occurs during sleep, and in fact sleep physiologists have speculated that the major function of
sleep is to allow the regeneration, maintenance, and repair of nerve tissue. The inventive process
of continuous, 24-hour administration of vitamins therefore optimizes the natural nerve repair
process which occurs during sleep. Conventional administration of vitamins during the daytime
fails to account for the significant need for B complex Vitamins at night.
4 Claims 1-15, 16-30 and 41-49, and 31-40 were directed to the first, second and third
aspects of the invention, respectively. Claims 31-40, which like the present claims are directed to
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