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« PBS NewsHour Examines Oral Argument in AMP v. Myriad -- Patent Docs Author Kevin Noonan Appears on Program | Main | What We May Learn from the Myriad Oral Argument »

April 17, 2013


"one of skill in the art could readily identify an antibody that binds to CD20 with similar affinity and specificity as does RITUXAN® . . . the skilled artisan could readily produce anti-CD20 antibodies using similar techniques, and screen such antibodies for those having an affinity and functional activity similar to RITUXAN®."

Isn't this precisely how the accused product was identified? The applicants were directly countering the Examiner's argument regarding enablement "no matter the specificity or affinity for the specific epitope on the circulating tumor cells." There was no need to "challeng[e] the examiner's understanding of the crucial terms." The examiner raised the issue of epitopes, and the applicants' argument suggests that the identity of the epitope is irrelevant.

If anything is disclaimed at all, it's antibodies lacking "similar affinity and specificity." The majority must think that "similar apecificity" implies "selective for the same epitope". Judge Plager (correctly, in my opinion) reads it as "selective for the same antigen".

It's always disturbing to see a patent shot down, on account of an argument that you yourself would have made with confidence. The only lesson I can take home here is that, when arguing for enablement, you have to explicitly state that you're not disclaiming anything.

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