Appeal No. 2003-0338 Page 2
Application No. 08/486,451
0.01% - 0.05% (w/v) of polysorbate 80;
an isotonic amount of sodium chloride; and
water
said composition having a pH of 6.0 + 0.5.
The examiner relies upon the following references:
Igari et al. (Igari I) 5,344,644 Sep. 6, 1994
Igari et al. (Igari II) 5,534, 269 Jul. 9, 1996
Prestrelski et al. (Prestrelski) 5,580,856 Dec. 3, 1996
Manning, “Stability of Protein Pharmaceuticals,” Pharmaceutical Research,
Vol. 6, No. 11, pp. 903-918 (1989)
Claims 21, 22, 24 and 26-37 stand rejected under 35 U.S.C. § 103(a) as
being obvious over the combination of Prestrelski and Manning. Claims 21, 22,
24 and 26-37 also stand rejected under 35 U.S.C. § 103(a) as being obvious
over the combination of Igari I and Igari II. After careful review of the record and
consideration of the issues before us, we reverse both rejections.
DISCUSSION
Claims 21, 22, 24 and 26-37 stand rejected under 35 U.S.C. § 103(a) as
being obvious over the combination of Prestrelski and Manning.
Given its brevity, the entire rejection is set forth below.
Prestrelski [ ] teach[es] the addition of several stabilizers for
a number of proteins including thrombopoietin. The stabilizers
used are buffers, such as citrate, acetate, phosphate and histidine,
agents to maintain isotonicity, preservatives, and the same polyols
as claimed herein as surfactants. These additaments are added in
amounts to prevent aggregation. Amount ranges for each additive
is shown. The composition is directed toward a lyophilized powder.
The patent does not teach that surfactants such as polyols are
used as surface adsorption inhibitors. However, this is a well
known fact in the protein art, as shown by Manning [ ] at page 911,
third paragraph. Therefore it would have been obvious to one of
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