Appeal No. 1997-3511
Application No. 08/233,663
Ground of Rejection
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Claims 1 - 9, 11 - 14, and 16 - 43 stand rejected under 35 U.S.C. § 103. As
evidence of obviousness, the examiner relies on an abstract of the German patent
4,001,451 to Schwinn, Wang, Zolton, Mathews, and Bhattacharva.
Background
The applicants describe the invention at pages 1 and 2 of the specification as
being directed to concentrated preparations of factor IX, useful as a bulk drug product,
wherein the compositions are either frozen, liquid, or lyophilized and comprise factor IX, a
bulking agent, such as glycine, and a cryoprotectant. Applicants state that the
cryoprotectant may be a polyol such as mannitol or sucrose. Applicants also state that the
composition may contain a surfactant and/or a buffering agent.
Discussion
In considering the issues raised by this appeal, we have carefully considered the
Examiner’s Answer of September 13, 1996 (Paper No. 23) and appellants’ Appeal Brief
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filed April 15, 1996 (Paper No. 20) . Our consideration of these documents, as well as the
1 On the record before us, the status of claim 43 is unclear. We note the statements appearing at
page 2 of the Appeal Brief and page 2 of the Examiner's Answer concerning the allowability of claim 43.
However,since the examiner has included claim 43 in the list of claims rejected, we have included claim 43
in our consideration of this appeal.
2 The Reply Brief, filed December 6, 1996 (Paper No. 24) was denied entry by the examiner in a
letter of January 21, 1997 (Paper No. 25) and this decision by the examiner was upheld on petition under 37
CFR § 1.181. (Paper No. 28 of May 14, 1997). Therefore, we have not considered this Reply Brief in
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