Appeal No. 2004-0250 Page 13
Application No. 09/226,412
“equivalents thereof.” Neither appellants nor the examiner have favored the record with
their position as to whether the claim limitation “pulmonary means” invokes the sixth
paragraph of § 112, and, if so, what corresponding structure is described in the present
specification. However, Gonda ‘250 describes a device that provides an aerosolized
insulin formation to be delivered to a patient’s lungs by way of inhalation through the
mouth of the patience. See, e.g., the abstract of Gonda ‘250 and Figure 3. For the
purposes of this appeal, we will consider that the Gonda ‘250 device is a “pulmonary
means” as this term is used in the claims on appeal.7
Thus, the question becomes whether Gonda ‘250 describes the administration of
a modified human insulin analog such as Lyspro in that manner. Gonda ‘250 states
that the methods described in that patent may be used to administer insulin analogs,
specifically stating: “Other general types of insulin analogs are presently used. One
type of new analog is sold by Lilly [the present real party in interest] under the name
Lyspro and this analog is absorbed faster after subcutaneous injection.” Gonda ‘250,
column 28, lines 53 through 56. See also, Gonda ‘250, column 29, lines 34 through 35
(“Other than Lyspro, the insulin analogs are not presently used for the treatment of
patients on a commercial scale.”).
From the above analysis, it is seen that Gonda ‘250 describes the method
required by claim 30 on appeal and thus constitutes an anticipation. The earliest date
of invention alleged by appellants in the Rule131 declarations of record is March 27,
7 In the event of further prosecution, appellants and the examiner should
address this issue and resolve whether “pulmonary means” does invoke the
requirements of 35 U.S.C. § 112, sixth paragraph.
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