Interference 102,413 Page 8
Pitha v. Muller
derivative. Pitha argues that the intrinsically amorphous12
nature of W-17 is shown by the product having to be freeze
dried. Pitha also argues the synthesis described in the13
making of HPBCD product W-17 was a synthetic procedure
analogous to the procedure described in Gramera patent
3,459,731 (PX-14) which resulted in a viscous liquid. As 14
other examples of intrinsically amorphous PBCD Pitha directs
us to laboratory notebook pages W-11 and W-44.15
Pitha describes the research he supervised performed by
Dr. Teresa Czajkowska which purportedly exhibit the synthesis
of intrinsically amorphous cyclodextrin derivatives which are
water soluble and capable of forming inclusion complexes with
drugs in water. The experiment C-70 is said to describe the
synthesis of PBCD cyclodextrin derivative. Pitha argues the 16
absence of indication of crystals, on page C-70, support the
conclusion that the product was intrinsically amorphous. 17
12PB page 15, lines 1-9.
13PB page 13, lines 10-16.
14PB page 13, line 15 to page 14, line 2.
15PB page 17, lines 3-6.
16PB page 17, lines 2-7.
17PB page 16, 3-5.
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