Appeal No. 2001-1907 Page 4
Application No. 08/694,315
DISCUSSION
1. Rejection under 35 U.S.C. § 112, first paragraph
Claims 23, 26 and 27 stand rejected under 35 U.S.C. § 112, first
paragraph, on the grounds that the specification does not enable any person
skilled in the art to which it pertains, or with which it is most nearly connected, to
make and use the invention commensurate in scope with the claims.
According to the examiner, the specification is only enabling for the use of
the activated immunoglobulin for i) inhibiting eosinophilia in mice intraperitoneally
injected with ragweed pollen; ii) increasing anti-TNP antibody titers in mice
immunized with SRBC; iii) decreasing DTH response in mice immunized with
SRBC; and iv) inhibiting the clinical symptoms of EAE in rats. The rejection
notes while the claims are drawn to a number of diseases, that “[t]here are no
data of any kind regarding the use of histamine activated immunoglobulin in
humans for any disease,” and that Appellants have “not established a nexus
between the administration to humans of histamine activated immunoglobulin
and treatment of disease commensurate in scope with [the] claim language.”
Examiner’s Answer, page 4.
The rejection then lists reasons why therapeutic methods using antibodies
are unpredictable. The examiner also addresses specific disease conditions,
such as HIV infection, and others that “do not involve an autoimmune component
in which eosinophilia is implicated in the pathology of the immunodeficiency.” Id.
at page 5. The rejection concludes that “[i]n view of the previous cited teachings
and in absence of data to the contrary, one with skill in the art would doubt that
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