Appeal No. 2001-0987
Application 09/169,109
On this record, applicants, and applicants alone, disclose that “loratadine can
exist in the form of two distinct crystalline polymorphs, each having distinctly different
physical properties” (Specification, page 2, first full paragraph). Applicants have
discovered specific solvents and experimental conditions, producing a distinctly different
polymorph form 2 of loratadine (Specification, page 3, last paragraph). Applicants
discovered that crystallization of loratadine (prepared as described in U.S. Patent No.
4,282,233) from toluene, t-butylmethylether, heptane, or mixtures thereof, produce a
polymorph form 2 loratadine. Applicants also discovered that using a t-butylmethylether
-toluene mixture is preferred (Specification, page 4, second paragraph). This
information stems from applicants’ specification, but not from the cited prior art. Further,
neither Villani nor Sims discloses or renders obvious a method for making polymorph
form 2 loratadine. As stated in In re Hoeksema, 399 F.2d 269, 274, 158 USPQ 596,
601 (CCPA 1968),
[I]f the prior art of record fails to disclose or render obvious a method for
making a claimed compound, at the time the invention was made, it may not be
legally concluded that the compound itself is in the possession of the public. In
this context, we say that the absence of a known or obvious process for making
the claimed compounds overcomes a presumption that the compounds are
obvious, based on close relationships between their structures and those of prior
art compounds. [footnote omitted]
The examiner relies heavily on this proposition of law set forth in Ex parte Hartop,
139 USPQ 525, 527 (Bd. Pat. App. 1962):
[M]erely changing the form, purity or another characteristic of an old
product, the utility remaining the same as that for the old product, does not
render the claimed product patentable.
According to the examiner, polymorph form 2 loratadine is merely another form of an old
product (polymorph form 1 loratadine) and both forms possess the same utility.
Accordingly, the examiner concludes that applicants’ claims, reciting polymorph form
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