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February 14, 2010


Jim Wasicak

One strategy for prosecuting method of treatment claims where no data is disclosed in the specification is to argue 101 and 112 utility/enablement based on structural similarities with the art and then present data of unexpected properties to overcome 103.

For 112, the MPEP provides: "[t]he test of enablement is whether one reasonably skilled in the art could make or use the invention from the disclosures in the patent coupled with information known in the art without undue experimentation. A patent need not teach, and preferably omits, what is well known in the art." MPEP 2164.01 citing In re Buchner, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991).

MPEP 2164(c) is also helpful here, "...it is not necessary to specify the dosage or method of use if it is known to one skilled in the art that such information could be obtained with-out undue experimentation. If one skilled in the art, based on knowledge of compounds having similar physiological or biological activity, would be able to discern an appropriate dosage or method of use with-out undue experimentation, this would be sufficient to satisfy 35 U.S.C. 112, first paragraph. The application need not demonstrate that the invention is completely safe." MPEP 2164(c).

For 101 utility, the MPEP provides: "[c]ourts have routinely found evidence of structural similarity to a compound known to have a particular therapeutic or pharmacological utility as being supportive of an assertion of therapeutic utility for a new compound. MPEP 2107.03 citing In re Jolles, 206 USPQ 885 (CCPA 1980).

For 103, one may assert that although one skilled in the art would reasonably expect the instant compound(s) to be useful based on the art, one skilled in the art could not reasonably predict the unexpected advantages of the instant compound(s) based on the art (and then provide comparative data showing the unexpected advantage(s)).

Clearly disclosing in vitro and/or in vivo data in the application is the best approach for prosecuting method claims. However, if you find yourself walking the enablement/obviousness tightrope due to lack of data disclosure, then consider the balancing act posed above.

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