Appeal No. 2000-0591
Application No. 08/311,291
According to the specification, 9-(4-hydroxy-3-hydroxymethylbut-1-yl) guanine,
an acyclic nucleoside also known as penciclovir or PCV, “[has] antiviral activity, and [is]
potentially useful in the treatment of infections caused by herpes viruses, such as
herpes simplex type 1 [HSV-1], herpes simplex type 2 [HSV-2] and varicella zoster
viruses [VZV].” Page 5.
Claims 22, 23, 29 through 31, 33, 35, 39 through 41, 47 through 49, 81 through
86 and 104 through 108, directed to pharmaceutical compositions comprising
penciclovir and to methods of treating HSV-1, HSV-2 and VZV using the compositions,
have been indicated as allowable by the examiner. Claims 27, 28, 43, 46, 51, 57
through 60, 99 through 103 and 109 through 120, directed to treating herpesvirus
infections generally using the compositions, are the subject of this appeal.
DISCUSSION
Enablement
According to the examiner, “the specification, while being enabling for the scope
of claims [directed to treating HSV-1, HSV-2 and VZV infections], does not reasonably
provide enablement for treating herpesviruses generally.” Final Rejection, paper no.
44. The examiner maintains that “the historical record has been that translating in vitro
results to in vivo results in the antiviral area does not resemble other areas, such as the
antibacterial area” (Answer, page 10), that “[d]espite intensive efforts, pharmaceutical
science has been unable to find a way of getting a compound to be effective for the
treatment of herpesviruses generally” (Id., page 4), and “an antiviral that operates
generally against a virus family is utterly without precedent” (Id., page 12), thus, “it is
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