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« Enfish, LLC v. Microsoft Corp. (Fed. Cir. 2016) | Main | EU Pharmaceutical Law Forum »

May 12, 2016


Come again? Claims 1 and 2 are identical, except claim 2 recites an additional step...and that addition makes the claim patent ineligible?

This is FUBAR. Completely and totally.

Hey Don,

The disparate characterization of Claims 1 and 2 cannot be reconciled with the recent Enfish v. Microsoft case which said the fact that an "exception" involved in the claimed subject matter can still pass step 1 of the Mayo/Alice framework as not being "directed to" the exception.

What if claim 2 depends from claim 1?

Unfortunately I think I understand why claim 2 is ineligible while claim 1 is. It has to do with what the claim is directed to, regardless of the actual claim elements. I fear that the section 101 framework is beyond repair and that even if claim 2 depends from claim 1 it might not be enough. Take this hypo:

Claim 1 is directed to an isolated peptide with a carrier; a nature-based product and let's assume that the carrier lends some "marked difference." Eligible under 101.

Claim 2 depends from claim 1, but is directed to a method of detecting a host immune response using the composition of claim 1. Whoops, now we're directed to a "law of nature" or "natural phenomena," and *regardless* of the fact that claim 1 is something that achieves a "marked difference" over a nature-based product, because we've now introduced a NEW judicial exception under section 101 category (and one that fits within the irretrievably screwed up Mayo test), that NEW judicial exception must be independently analyzed, REGARDLESS of claim 2's dependency status. And because law of nature is so much harder to unravel than a "nature-based product", good luck getting this claim.

I've basically given up trying to patent diagnostic method claims or method claims that involve a biological process, until this framework is abolished or modified.

Sadly, I think the Sequenom case won't help much here; that isn't a law of nature, and for whatever reason, (I feel like I'm taking crazy pills here), everyone is treating a method claim reciting a nature-based product under the Mayo test for "natural phenomena" when I explicitly understood natural phenomena to be more akin to a law of nature.

Aka, a peptide = nature based product
Immune response = natural phenomena
e=mc2 = law of nature

Ergo, cffDNA to me is a nature-based product, and the method claims should not be analyzed under a natural phenomena standard. But they were, and I seemingly stand alone in my protest to its classification that way.

If I were to have handled the Sequenom case I would have pushed the fact that Myriad clearly states that method claims drawn to nature-based products are eligible, and not entertained this whole Mayo framework for the method claims. The PTO seems to agree with me in their treatment of "nature-based products" by not funneling them through the garbage disposal of the Mayo test.

I suppose that's my rant for the day, I find this whole situation to be so frustrating, not only because the test is bad, but the application of it is so inconsistent at times, e-specially by the courts. The patent office is, surprisingly, much more coherent than the courts have been.

I urge practitioners in their Responses with the PTO (and court filings) to clearly take the time to think about what category the purported judicial exception falls into, and challenge that classification if possible.

Regarding claim 5, if a doctor sends a sample out to get tested and then administers vitamin D to the patient based on the results, is there direct infringement? If not, can there be any joint or contributory infringement or inducement to infringe? In other words, is this claim practically useful?

I totally agree the current situation is frustrating and detrimental with respect to claiming diagnostic methods based on new, useful and unobvious correlations that can a lot of time and effort to discover.

Regarding claim 2:

"there is no meaningful limitation... in this step that distinguishes it from well-understood, routine, and conventional data gathering activity engaged in by scientists prior to applicant's invention"

This language has its root in the Mayo decision and it has been the bane of diagnostic method claims ever since. The problem is that the USPTO and the courts have defined the art too broadly. The art in question is not science in general. It is not some broad category of science, such as molecular biology or biotechnology, The field of endeavor is diagnosis of a particular disease. Given the scenario that prior to this patent disclosure, nobody recognized a correlation between expression of JUL-1 and julitis, the detection of JUL-1 WAS NOT conventional activity engaged in by PERSONS ATTEMPTING TO DIAGNOSE JULITIS.

I don't know if this particular point has been directly argued in a court. I do know that examiners in TC1600 have brought it up in discussion. The policy makers will have none of it, for fear (probably justified) of appearing to defy the courts.

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