Appeal 2007-1673
Application 10/056,237
actively cooling a heat exchange structure within said cavity by
flowing a fluid through a dual flow conduit having one or more heat transfer
members thermally coupled thereto;
freezing said medium within said vessel to preserve said
biopharmaceutical product.
The Examiner relies upon the following references as evidence of
obviousness:
West US 2,114,642 Apr. 19, 1938
Kalhori, "Studies on Heat Transfer From a Vertical Cylinder, With or
Without Fins, Embedded in a Solid Phase Change Medium," Transactions
of the ASME, Journal of Heat Transfer, Vol. 107, 44-51 (Feb. 1985).
Wisniewski, "Large-Scale Freezing and Thawing of Biopharmaceutical
Drug Product," Proceedings of the International Congress, Advanced
Technologies For Manufacturing of Aseptic & Terminally Sterilized
Pharmaceuticals & Biopharmaceuticals, 133-139 (Feb. 1992).
Appellants' claimed invention is directed to a method of preserving a
biopharmaceutical product by freezing a medium comprising the product in
a vessel whose interior wall is actively cooled. Also, a heat exchange
structure within the cavity of the vessel is actively cooled by flowing a fluid
through a dual flow conduit having one or more heat transfer members
thermally coupled thereto.
Appealed claims 1-8 and 27-42 stand rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Wisniewski in view of Kalhori and
West.
The Examiner has withdrawn the rejection under 35 U.S.C. § 112,
second paragraph.
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