Appellant wins reversal of written description and obviousness rejections in Ex parte VAGHEFI

From Ex parte VAGHEFI

Of written description and genus/species:


In particular, Appellants contend that the written description
requirement for a claimed genus may be satisfied through sufficient
description of a representative number of species. Appellants cite to MPEP §
2163.05(b) for the proposition that a “representative number of species”
means that the species which are adequately described are representative of
the entire genus. Appellants contend that even where there is substantial
variation within the genus, disclosure of a sufficient variety of species that
reflect the variation within the genus would properly satisfy the written
description requirement for broadening the scope of the claims.



Of the details:


The Examiner finds that the disclosure of specific species of opioid
agonist supports the explicitly-disclosed compounds, but does not support
disclosure of the genus of opioid agonists. (Ans. 5.) The Examiner does not
reply to Appellants implied query (App. Br. 13) regarding how many species
must be disclosed to comprise a “representative number.”
Appellants contend that a “disclosure of a functional recitation of
known compounds in the specification may be sufficient as adequate
description for such compounds.” (App. Br. 13)(citing In re Herschler, 591
F.2d 693, 697 (CCPA 1979)). Appellants further contend that the Courts, in
certain circumstances, have held that disclosure of a single species supports
a genus claim. Appellants contend that in Smythe, the disclosure of a single
species, air, which was inert to a liquid, was sufficient to support a claim to
the genus “‟inert fluid media‟” because the description of the properties and
functions of the air or other gas would suggest to a person skilled in the art
that appellant‟s invention includes the use of “‟inert fluid‟” broadly. (App.
Br. 13)(citing In re Smythe, 480 F.2d 1376, 1383 (CCPA 1973)).



Bottom line:

We agree with Appellants that the disclosure of 68 species of
“pharmaceutically acceptable opiates and opiate-based derivatives that are
suitable for use as a therapeutically effective analgesic” (App. Br. 18; Spec.
7) is a “representative number of species” to suggest the genus “opioid
agonist” to the skilled pharmaceutical formulator.


Of negative limitations:

We agree with Appellants that the original disclosure in the
Specification p. 3, ll. 8-10 would reasonably support the negative limitation,
“wherein the composition does not include an antagonist of the water soluble
compound capable of abuse” in claim 1. We find that one having ordinary
skill in the pertinent art would recognize from the disclosure page 3 that
Appellants invented compositions including that limitation.

As to obviousness:

The burden is on the Examiner to set forth a prima facie case of
unpatentability. See In re Glaug, 283 F.3d 1335, 1338 (Fed. Cir. 2002).
We do not find that the Examiner‟s evidence, Cain, is sufficient to support a
prima facie case of obviousness. “[O]bviousness requires a suggestion of all
limitations in a claim.” CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) (citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).
In particular, we do not find that the Examiner has provided evidence in the
prior art wherein each of a plurality of microspheres is wetted with a coating
of the water insoluble matrix material, as claimed.