Appeal No. 2001-1020 Page ~PAGE ~4~
Application No. 09/063,524
necessarily present in the prior art product. See Ex parte Skinner, 2 USPQ2d
1788, 1789 (Bd. Pat. App. Int. 1986) (“[T]he examiner must provide some
evidence or scientific reasoning to establish the reasonableness of the examiner’s
belief that the functional limitation is an inherent characteristic of the prior art”
before the burden is shifted to Applicants to disprove the inherency.).
Here, we agree with Appellants that the examiner has not shown the
claims to be anticipated by either the PDR or Goodman & Gilman. We find
ourselves in agreement with the following position, stated in the Appeal Brief:
Claims 1 and 2 are compound claims, covering a single compound.
. . . Neither of the references teach a single compound, but teach
Premarin as a mixture of estrogenic components, and neither of the
references teach anything about [the specifically claimed
compound] at all. Claim 3 is a compound claim which covers [the
compound] in greater than 1 percent purity, which is substantially
more pure than it is in Premarin. Neither of the references
discloses or teaches [the compound] in greater than one percent
purity. . . . Claims 17 and 18 are pharmaceutical composition
claims which cover a pharmaceutical composition containing [the
compound] (or a salt of its 3-sulfate ester) as the sole active
ingredient plus a pharmaceutical carrier. Neither of the references
discloses a pharmaceutical composition containing [the compound]
(or a salt of its sulfate ester) as the sole active ingredient in the
composition. As none of the references contain all the limitations
required by the claims, . . . Claims 1-3 and 17-18 are not
anticipated by the PDR or Goodman and Gilman.
Page 4.
In addition, the examiner’s reliance on Ex parte Reed is misplaced. Reed
does not reflect the current state of the law. It is by now well-established that the
degree of purity of a compound can render it patentable over the same
compound in an unpurified state, even if both materials share the same utility.
See, e.g., In re Bergstrom, 427 F.2d 1394, 1401, 166 USPQ 256, 262 (CCPA
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