Appeal No. 2003-0564 Page 6
Application No. 08/964,498
Rather, the method is disclosed to require “oral administration . . . of a
composition containing at least one phosphate-binding polymer that is non-toxic
and stable once ingested.” Page 2. Holmes-Farley defines “non-toxic” to mean
that “neither the polymers nor any ions released into the body upon ion exchange
are harmful,” and defines “stable” to mean that “the polymers do not dissolve or
otherwise decompose to form potentially harmful by-products, and remain
substantially intact so that they can transport bound phosphate out of the body.”
Page 3.
The examiner has argued that “the fact that both the polymers of [Holmes-
Farley] and [Howes] contain quaternary amine groups would inform one of
ordinary skill that, with regard to methods of use of [sic] implicating the
quaternary amine, the polymers will be functionally similar.” Examiner’s Answer,
page 4. We understand this to mean that, in the examiner’s view, those of skill in
the art would have expected both Holmes-Farley’s polymers and Howes’
polymers (and any other polymer comprising quaternary ammonium units) to
bind phosphate.
The examiner has presented no evidence to support this position, but it
would make no difference if he had. Even assuming the examiner is correct,
Holmes-Farley clearly discloses that not all phosphate-binding polymers are
appropriate for use in treating hyperphosphatemia. In addition to binding
phosphate, the polymers must also be non-toxic and stable, as those terms are
defined by Holmes-Farley. The examiner has presented no evidence that those
skilled in the art would have recognized Howes’ polymers as meeting these
Page: Previous 1 2 3 4 5 6 7 8 Next
Last modified: November 3, 2007