Interference No. 104,544 Paper149
McDonald v. Miyazaki Page 25
[72] The exhibit filed in support of the declaration explicitly refers to work done with TSF but
does not refer to any specific amino acid sequence for, or to any fragments of, TPO
[1054, Exh. 1].
[73] According to the declaration, the tested TPO "contained both N and C terminuses of the
molecule" [1054, T3.1.b].
[74] In the next sentence, the declaration states that it was the 15 kD form that was tested
[1054, Dec. ý31b]:
This preparation was a truncated form of the molecule that had 15 kd
molecular weight (MW).
[75] As noted above, the specification associates the 15 kD form with the C-terminal
fragment. It does not associate it with the N-terminal fragment plus a little bit of the C
terminal fragment.
[76] Following entry of Dr. McDonald's declaration, all claims were allowed. The examiner
indicated in his reasons for allowance that allowance was [1004 at 2, emphasis in
original]:
Based on the activity profile elicited by the C-terminal fragment of TPO
(i.e. residues 154-332) in MAIDS model, the therapeutic amount of a
C-terminal fragment is considered to constitute an amount sufficient to
increase platelet cell counts in a thrombocytopenic patiento by at least
20% or greater above a baseline count with[in] 2 to 4 days after
C-terminal fragment administration. Also, the in vivo assays disclosed in
the specification is considered to be adequate for the fragment smaller
than 154-332 amino acid residues of TPO.
Any comments considered necessary by Applicant must be
submitted no later than payment of the Issue Fee and, to avoid
processing delays, should preferably accompany the Issue Fee. Such
submissions should be clearly labeled "Comments on Statement of
Reasons for Allowance."
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