Appeal No. 2003-1794 Page 13
Application No. 09/804,969
In this case, the examiner found the specification’s disclosure that the
claimed polynucleotides encode a phospholipase was not sufficient to establish
their utility, because
[e]ach phospholipase . . . catalyzes the hydrolysis of many
phospholipids having different structure and functions. Thus, each
phospholipase is expected to have a specific substrate(s), i.e., a
chemical function, and biological role. The specification fails to
disclose a specific chemical function of the polypeptide of SEQ ID
NO:15, its biological role or relationship to any disease, or any
specific real world use, i.e., substrate. . . . It appears that the main
utility of the polypeptide and nucleic acid is to carry out further
research to identify the biological function and possible diseases
associated with said function. . . . Utilities that require or constitute
carrying out further research to identify or reasonably confirm a
“real world” context of use are not substantial utility. Thus, the
claimed invention has no specific or substantial asserted utility.
Examiner’s Answer, pages 3-4 (emphasis in original).
Appellants argue that
the association between phospholipases and a variety of different
diseases has long been recognized by skilled artisans, . . . for
example, the relationship between phospholipases and
development . . ., the relationship between phospholipases and
cancer . . ., the relationship between phospholipases and infectious
disease . . ., and the relationship between phospholipases and
inflammation. Thus, phospholipases, such as the presently
describe protein, have a well-established utility. . . . The present
specification also teaches that phospholipases are associated with
a wide variety of cellular functions, including “development,
inflammation, infectious disease, and cancer. . . . Thus, the skilled
artisan would readily appreciate the utility associated with the
provision of a novel human sequence related to phospholipases.
Appeal Brief, pages 5-6. Appellants attached to the Appeal Brief abstracts from
scientific papers that purportedly show the asserted relationships between
phospholipases and various processes and diseases.
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