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« Court Report | Main | News from Abroad: High Court of Australia Hears Myriad Appeal »

June 15, 2015

Comments

For diagnostic method claims using an immunoassay, I have been adding the specific steps of forming a complex between an analyte in a sample and an antibody that specifically binds to the analyte and detecting the presence of the complex, and then arguing that the formation of the complex is a transformation. This is the response from the PTO:

"binding an antibody to a protein in an immunoassay
results in a temporary and reversible change of the protein, this is not a transformation
in the in the legal sense of the word as there is no fundamental change in the nature of
the protein itself."

We have not yet filed an appeal based on this argument, but are preparing to take a case or six up on this ground where we have obviated all other rejections.

(We are also arguing lack of pre-emption, as other methods can be used to detect the analyte, but I am particularly interested in this MoT issue.)

Comments on this issue would be appreciated.

Many things in life are temporary. We can get utility from some of them in the time that they are present.

I suppose if one invented table salt (assuming it wasn't found in nature) it would likewise be rejected for lacking covalent bonds and going back to Na+ and Cl- if water was added?

Or a new micelle is unpatentable, because if oil is added the micelle will be broken up into individual lipids?

I would think that your antibody-protein complex will be sticking around for as long as you want it to, or at least long enough for you to get utility from it by detecting the protein.

How about adding that the antibody/analyte complex is formed and sustained during the period of the test. Adding that time window to the claim cuts off the Examiner's ability to rely on what happens thereafter.

The comments to this entry are closed.

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