Appeal No. 2001-1150 Page 3
Application No. 09/767,764
Caplan, are cited for their teaching that there is no “magic bullet” for the
treatment of CFS. Because of the varying symptoms of CFS, the rejection
asserts that there is not an art recognized definition of a therapeutic effect for
CFS, and that the specification fails to enable the skilled artisan to determine
whether any improvement was due to the administration of lymphocytes. See id.
at 6-7.
The examiner notes that while “[t]he specification discloses treating six
patients with autologous lymphocytes isolated from the patient’s lymph node and
stimulated with antibody against CD3 and with IL-2,” the results varied between
patients and not all of the patients demonstrated improvement. Id. at 4-5. In
addition, the examiner, relying on Goldenberg, faults the data in the specification
for not having a control, i.e., for failing to compare patients receiving the
treatment method of the invention to patients receiving a placebo. See id. at 6-7.
The rejection concludes:
Applicants have not provided adequate guidance for one of
skill to determine when a therapeutic effect has been obtained or
whether the autologous lymphocytes administered to CFS patients
are responsible for any of the observed effects (either positive or
negative). Given the lack of a definition of a therapeutic effect for
CFS in the specification and in the art at the time of filing, the
heterogeneity in CFS and variability of symptoms of CFS over time,
the art recognized need to compare CFS treatments to placebos
taken with the data provided in the specification, it would require
one of skill undue experimentation to determine how to use the
cells or methods claimed to treat CFS.
Examiner’s Answer, pages 7-8.
Appellant argues that “the Examiner just plain does not believe the data,”
and that the declaration of Dr. Klimas establishes that the specification provides
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