Appeal No. 1999-1425
Application No. 08/393,321
coming forward with evidence or argument shift to the applicants. Id. In order to meet that
burden the examiner must provide a reason, based on the prior art, or knowledge
generally available in the art as to why it would have been obvious to one of ordinary skill in
the art to arrive at the claimed invention. Ashland Oil, Inc. v. Delta Resins & Refractories,
Inc., 776 F.2d 281, 297, n.24, 227 USPQ 657, 667, n.24
(Fed. Cir.), cert. denied, 475 U.S. 1017 (1986).
On the record before us, the examiner has not met the initial burden of establishing
why the prior art, relied on, would have led one of ordinary skill in this art to arrive at the
method of claims 1 - 9. Sambrook, while isolating plasmids from cells by disrupting the
cells does not describe any “mechanical” methods of doing so. Sauer, while describing
the mechanical disruption of cells using a microfluidizer, is concerned with isolating
proteins (page 1330, column 1, first paragraph of the Introduction) and does not suggest
that the methodology described would be suitable for use in isolating intact DNA plasmids.
Further, we have the statement from Sambrook which suggests that large plasmids are
susceptible to damage and should be released from cells by gentle lysis. (Page 1.22,
paragraph 1). Thus, in our opinion, the examiner has provided no evidence or facts which
could reasonably be read to suggest or direct one of ordinary skill in this art to use the
microfluidizer of Sauer in the plasmid isolation process of Sambrook.
In addition, neither reference suggests or describes the use of an operating
pressure of 750 to 4,000 psi. While the examiner urges that it would be a matter of routine
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