Appeal No. 2003-1716 Page 6
Application No. 09/946,205
Drugs 45(2): 232:258). In all of these studies, the two active substances
carvedilol and hydrochlorothiazide were sequentially administered in the
form of individual tablets. A fixed combination of the two active
substances could not be realized until the present invention.
A combined product was not earlier developed because the two active
substances, carvedilol and hydrochlorothiazide, have different solubilities
and, when granulated together, gave end products with inadequate active
substance release and bioavailability. Thus, it was problematic to provide
the two active substances as a combination preparation, such as a tablet.
An object of the invention is to provide a solution to these problems.
Those passages, however, do not establish that persons skilled in the art had tried, but
failed, to prepare a tablet comprising carvedilol, hydrochlorothiazide, and at least one
pharmaceutically acceptable additive. The above-quoted passages in the "Background
of the Invention" section of applicant's specification do not mention any efforts to
prepare a tablet containing active substances and "at least one pharmaceutically
acceptable additive."
Further, the above-quoted passages in applicant's specification, although
somewhat cryptic, suggest that carvedilol and hydrochlorothiazide were granulated
together to give end products. This suggests, at the time applicant's invention was
made, that tablets containing carvedilol and hydrochlorothiazide could be formed. That
the end products referenced in the specification at page 2, line 25, had "inadequate
active substance release and bioavailability," does not mean to say that end products
were not formed. Moreover, claim 1 on appeal does not require that applicant's tablet
be a pharmaceutically acceptable solid dosage form combination preparation; nor does
claim 1 require that applicant's tablet have any specified degree of active substance
release or bioavailability.
That "[a] combined product was not earlier developed," as stated in the
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