Appeal No. 2002-0783 Page 4
Application No. 09/268,957
showing of good and sufficient reasons why they were not earlier presented." In Paper
No. 16, mailed February 13, 2003, the examiner determined that Exhibits A-E would not
be admitted because applicant has not provided a showing of good and sufficient
reasons why they were not earlier presented. Accordingly, those exhibits are not part of
the administrative record.
In other words, applicant's Reply Brief is technically of record. But applicant's
argument in the Reply Brief, with respect to the propriety of combining references, is
unavailing because that argument is based on Exhibits A-E which are not of record.
Cf., In re Mehta, 347 F.2d 859, 866, 146 USPQ 284, 289 (CCPA 1965) (Unsworn
"Exhibit" can be taken merely as argument and not to establish facts).
The Merits
El-Rashidy discloses a composition comprising an osmotic agent; a swellable
hydrophilic carrier; and a water dispersible polymer in combination with an effective
amount of water soluble drug (active ingredient) for providing controlled release of the
drug by sublingual route. Additionally, El-Rashidy discloses a T90 value and a ratio of
the amount by weight of osmotic agent to the amount by weight of swellable hydrophilic
carrier which meet the terms of claim 1 on appeal.
El-Rashidy discloses a composition for the controlled release of water soluble
drugs by sublingual mode of administration, focusing attention on the specific drug
apomorphine hydrochloride. As best seen in Example 19, El-Rashidy discloses
apomorphine hydrochloride for treating male erectile dysfunction. According to El-
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