Appeal No. 2006-3290 Page 10
Application No. 10/072,823
lupulone into a composition for the treatment of cancer. Answer, page 5.
Accordingly, we are not persuaded by Appellant’s argument.
The same is true of Appellant’s argument relating to Exhibit 38 and Exhibit
49. With reference to Exhibit 3 Appellant asserts “that optimization of drug
combinations is not straight forward and in fact requires ‘clinical empiricism and
trial and error’.” Brief, page 9. Appellant, however, fails to acknowledge that this
statement was made with respect to a specific cancer – childhood acute
lymphoblastic leukemia (ALL). According to Exhibit 3 (page 1, second
paragraph, endnotes omitted),
childhood acute lymphoblastic leukemia (ALL), a disease that 25
years ago claimed the lives of the majority of ALL patients . . . today
is up to 90% curable. Over that 25-year period, no new drugs have
entered standard treatment protocols; rather, it has been the
optimization of combinations of old drugs, based entirely on clinical
empiricism and trial and error, that has yielded such effective
results.
We find no suggestion in the reference that this statement applies to the
treatment of cancers generally, or to the class of compounds10 taught by the
references before us on appeal. Accordingly, we are not persuaded by
Appellant’s argument.
8 http://www.nature.com/cgi-taf/DynaPage.taf?file=/nm/journal/v9/n5/full/nm0503-510.html. We
note that this website directs attention to the following article: Golub, “Mining the genome for
combination therapies,” Nature, Vol. 9, No. 5, pp. 510-511 (2003).
9 Johnson et al. (Johnson), “Antagonistic Interplay between Antimitotic and G1-S Arresting Agents
Observed in Experimental Combination Therapy,” Clin. Cancer Res., Vol. 5, pp. 2559-2565
(1999).
10 In this regard, we note that Exhibit 3 discusses combination therapy using mercaptopurine and
methotrexate. Appellant makes no attempt to establish that these are the same class of
compounds as oridonin and lupulone.
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