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« Court Report | Main | EMA Publishes Guidelines for Biosimilar Antibodies - Part I »

November 29, 2010


...the children all snug in their beds with visions of complicated process algorithmic calculations that induce serotonin and melatonin dancing in their heads.

And infringement would be shown how?

...so just because the Office proclaims the change "not" to be substantive, we are supposed to agree?

One wonders what the world would be like if we all followed that path. If Tafas and GSK followed that path.

"On appeal, Mikkilineni argued that the Interim Guidelines constituted substantive rules that were improperly promulgated without notice and comment rulemaking, and that the Office improperly rejected his application. "

Let me guess, this guy had David Boundy as his attorney.

Everything looks like a substantive rule when all you've got is a non-statutory process.

No, 6, if Mikkilenini had had a lawyer with some competence in the administrative law, he wouldn't have brought the case. It wasn't me. (I've advised several folks to not bring dumb cases -- some listen, some don't, and they're getting creamed.)

The Federal Circuit got the right result, but goofed a bit around the edges. For example, examination guidelines are "interpretative" not "interpretive" (look at the statute, dears), and the opposite of "interpretative" is "legislative" not "substantive." But we can look past that.

It's also crystal clear that the non-final rejection is not independently reviewable under § 704 first sentence. Once the PTO issues a final action, and if a procedural breach in the examiner's work colored subsequent proceedings, then Mikkilenini has a claim for review of the non-final action under § 704 second sentence, but he's not there yet.

The Office bad a big goof, notice and comment is required under OMB's Good Guidance Bulletin -- but the remedy for that breach does not lie in a court, and it wasn't at issue here.

The case does give us going-forward instruction. We now have a clear adjudication that examination guidelines are "interpretative." That means they have very limited binding authority against applicants--the PTO may not foreclose alternative positions. "Interpretative" also means binding minima against the Office (even the Board, the piratical footnote 8 of the Board's decision in Ex parte Bilski, and the "neither appealable nor petitionable" disclaimer gibberish at the beginning, notwithstanding).

If the PTO maintained consistency with the position it argued here and in Jung, we'd be golden.

Fat chance of that.

"The Office bad a big goof, notice and comment is required under OMB's Good Guidance Bulletin "

OMB has no power here! And just btw, Kev. just said that they did do notice and commenting. And I seem to remember them doing it.

"No, 6, if Mikkilenini had had a lawyer with some competence in the administrative law, he wouldn't have brought the case. "

Probably true. Nevertheless, you know he got the idea for this challenge somewhere. He didn't just make it up off the top of his head. He's been reading some [redacted] somewhere, some [redacted] talking about Guidelines and Substantive Rule Making to be exact. Take care what your tomfoolery causes others to do.

I just had quite a thought, what if this is AI's caae?

>>> OMB has no power here!

I am well aware that that sentiment pervades a distressingly high fraction of the PTO's staff, junior to quite senior. They don't care all that much about final judgments of courts either, even on issues that the PTO fully litigated and lost fair and square.


As you well know (and valiantly uncovered and exposed), the noise that is the Office is above the law.

I commend you on your diligence. Keep up the good work.

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