15. To understand Tables 10-15, one must first
appreciate Table 7, which describes four (4) compositions, which
we designate as 1 through 4:
1. r-hCG/5000/S01 contains 10000 units r-hCG and 102.6 units sucrose
2. r-hCG/5000/M01 contains 10000 units r-hCG and 54.6 units mannitol
3. r-hCG/10000/S01 contains 20000 units r-hCG and 102.6 units sucrose
4. r-hCG/10000/M01 contains 20000 units r-hCG and 54.6 units mannitol5
16. One immediately notes that the ratio of sucrose to
r-hCG is slightly less than twice the ratio of mannitol to r-hCG
[102.6/10000 = 0.0.01026 whereas 54.6/10000 = 0.00546 for
Compositions 1 and 2, respectively, and 102.6/20000 = 0.00513 and
54.6/20000 = 0.00273 for Compositions 3 and 4, respectively].
17. According to the specification, Tables 10 and 11
report the purity determined by HPSEC6 for 5,000 and 10,000 IU
strength respectively. The data is said to show that even after
three weeks at 50°C, the purity is higher in the formulations
containing mannitol compared to the formulations containing
sucrose (specification, page 4, lines 13-16).
In Table 7, the formulation is identified as "r-hCG/1000/M01" (emphasis
added). Based on other Tables we discuss, infra, we suspect the 1000 is a
typographical error and that applicants meant 10000. Accordingly, we use 10000
and not 1000.
We are told in the specification that purity was measured by HPSEC
analyses using standard conditions set out in the specification. However,
there is no testimony, for example, in the form of a Rule 132 declaration,
which explains (a) the reason why the test is being used and why the data is
being relied upon; (b) how the test is performed; (c) how the data is generated
using the test; (d) how the data is used to determine a value; (e) the
acknowledged accuracy of the test; and (f) any other information which would
aid the USPTO, including the board, in understanding the significance of the
test or data. Hence, on this record, we do not know what weight, if any,
should be assigned to HPSEC tests and data generated therefrom.
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