Appeal No. 2003-1042 Page 6
Application No. 09/019,764
In response, Appellants assert that:
One skilled in the art would have turned to Table 3 for
guidance as to the scope to be given the word “approximately” in
the claims because Table 3 reports the repeated measurements of
actual concentrations of the preservative components of several
vaccine samples. Table 3 shows that when six samples of vaccine
plus preservatives were subjected to HPLC to determine the actual
concentrations of the various preservative components, the relative
standard deviations of the measured amount of each preservative
were found to be no more than 2.0%. This can be seen in the right
part of Table 3, under the heading “R.S.D.” This is also stated at
page 11, lines 20-21: “For six repeated injections in the same run,
the relative standard deviations were better than 2.0% for all
compounds.” Thus, one skilled in the art would have interpreted
Table 3 and the accompanying description at page 11, lines 20-21
as a teaching that the when [sic] the inventors repeatedly
measured the amount of preservative component in a given
vaccine preparation, the amount that each component varied was
highly reproducible and very small, i.e., the variability was limited to
a level of + 2.0%. This would have implied a corresponding ability
to make vaccines having this level of variability of the components.
Together, this teaching and its implication would lead one skilled in
the art to conclude that the amount of variability is vastly different
from the 47% to 67% variation from the recited concentrations
disclosed in Cleland.
Appeal Brief, pages 8-9.
The examiner, however, disagrees, asserting that one of ordinary skill in
the art would just as likely look to Table 5 to determine the appropriate
construction of approximately. Table 5 teaches concentrations of benzyl alcohol
as ranging 0.5% to 2%. See Examiner’s Answer, page 6. In addition, the
examiner also points to Table 6, which illustrates “stability studies conducted on
preparations containing 0.18% methyl paraben sodium and 0.02% propyl
paraben sodium . . . [which] would seem to indicate that these are values which
Page: Previous 1 2 3 4 5 6 7 8 9 10 Next
Last modified: November 3, 2007