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March 04, 2014



Another unfortunate by-product of the interference by Our Judicial Mount Olympus with respect to the patent-eligibility standard(s) under 35 USC 101. Having dealt with how the Examiner Corps applies/misapplies MPEP 2106(II), I've got no confidence they'll do anything but create further chaos with these new guidelines. We'll be spending years and client money trying to sort out how these new USPTO guidelines are applied.

Unfortunately, there are no guidelines for determining when a limitation "preempts" the "law of nature" and when it does not, or which limitations are "significantly different" and which not- we have been battling stubborn Examiners over this issue in 101 rejections now for a while, with no recourse in the face of their arbitrary application of the "Guidelines". Sadly, the March 4 Guidelines do not provide any additional clarification.

Lot's of discussion on certain blogs about preemption and abstraction.

Preemption is what all claims do.

Abstraction is contained in all but the most worthless explicit picture claims.

Mirroring David's post, empty blatherings simply do not help. This is not workable guidance where the guidance is most needed.

The memo does remove doubt that Myriad does not just apply to isolated nucleic acids... it indicates that any naturally ocurring substance that is isolated and/or purified is not eligible unless it is made to be significantly different from its makeup in its original source. I wonder if putting a naturally ocurring substance into a pharmaceutical formulation will no longer be enough to qualify under 101.


Did anyone have doubts that the law as applied to the facts of the Myriad case would not be applied (as law) to a case with different facts in a manner that went beyond isolated nucleic acids...?

To that misapprehension of how law works, I remain...

Well, I recently had claims to an isolated nucleic acid (viral genome) rejected under 101 but claims to the isolated virus allowed. Which one is more naturally ocurring?

Sorry John, but your comment to claims not present have nothing to do with my comment on how law is applied.

Then I guess you are law school faculty, not a practicing patent attorney.

And I guess that you SHOULD NOT BE a practicing attorney if you do not understand the basics of how law is applied to the facts of a case.

To answer your initial question to me, it was indeed uncertain how the Myriad holding would be applied to “naturally occurring” compositions that were not isolated segments of DNA. For example, see this thread on this very blog: http://www.patentdocs.org/2013/06/supreme-court-issues-decision-in-amp-v-myriad.html

In that thread, I notice now you responded to me and stated “I am not sure that you understand why "the exclusive right to isolate..." could not be given in a patent to anyone.” Patents do not give their owners the exclusive right to do anything but exclude others from making, offering for sale, selling and importing what is covered by the claims. To suppose it is an affirmative right is to misapply the law, and I wonder how you can apply law to the facts of a case if you do not understand the law at the outset.

You may now dismount your high horse and go back to your lecture notes.

Sorry John, but even referencing another discussion which shows that you do not understand how law works will not convince me that you understand how law works.

Here you seem intent on misconstruing my question to you on a previous blog. Yes, I do know that patents are exclusionary. You missed a negative in my question.

You really should not be on a high horse yourself when you accuse others (incorrectly) of being on high horses. You look rather foolish doing so.

I think we are both close to looking foolish at this point so let us agree that the new guidelines make it clear that the patent office will now disallow claims to all naturally occurring substances if those substances are not markedly different from how they exist "in nature." Isolation and purification are not enough. How many patent / application claims this affects is anyone's guess, but my original point is that the patent office has until very recently been allowing claims to isolated, naturally occurring substances, but now it will not. This could mean, for example, a patent claim to an immunogenic peptide that is a fragment of a naturally occurring protein is suddenly invalid. Does putting this peptide into a vaccine formulation make it a patentable composition? What if the peptide has a different or no glycosylation pattern that makes it different from the naturally occurring protein, but that is not spelled out in the application because it was not known, and there was previously no reasons to emphasize that distinction for subject matter purposes?

We will have to wait for the courts to tell us what markedly different means but in the interim the patent office will no doubt apply this inconsistently.

"[I]t was indeed uncertain how the Myriad holding would be applied to 'naturally occurring' compositions that were not isolated segments of DNA."

I have to agree with this statement. Indeed, the new PTO guidelines say on page 1 that "WHILE THE HOLDING IN MYRIAD WAS LIMITED TO NUCLEIC ACIDS, Myriad is a reminder that claims reciting or involving natural products should be examined for a marked difference under Chakrabarty," (emphasis added).

In other words, the PTO still maintains that Myriad has no binding legal implications beyond nucleic acids. To the extent that the PTO thinks it legally obligatory to reject claims to isolated proteins, microbes, etc., the PTO evidently traces this obligation to Chakrabarty, not Myriad.

At the 'risk' of 'looking foolish' (not really a concern for me), I will try to educate John by noting that facts are always case specific, but that law is the item that supersedes - and is applied to each case's facts.

To think that the law after Myriad was in anyway 'uncertain' as to its applicability beyond the facts of the Myriad case is itself foolish.

Can anyone explain why claim 2 of Example E in the Guidelines is patent eligible in view of Mayo? The Example doesn't tell us to go back in time prior to the development of PCR to analyze this claim. As such, wouldn't the steps of the claim (apart from the primer sequences - products of nature) "involve well-understood, routine, conventional activity previously engaged in by researchers in the field" as stated in Mayo at 1294. If there is anything that is well-understood, routine conventional activity in the field of molecular biology, its PCR. Thus, in application, claim 2 would preempt use of the claimed primer sequences in most all standard PCR reactions thereby, for all practical purposes, giving claim 2 essentially the same scope as claim 1 (unless there were other uses of BOTH primer sequences together beyond PCR). I guess the primer sequences of claim 1 could be used as functionalized probes, but you wouldn't infringe claim 1 unless you used both of the sequences together. Furthermore, most PCR reactions are going to require at least 20 cycles. So again, PRACTICALLY SPEAKING, not much difference in scope of claim 1 and 2 as applied in every day situations.

Assuming that claim 2 is eligible under 101, would it remain eligible if you didn't specify the number of times you repeat steps a and b - instead claim "repeat steps a and b until a detectable number of copies of the double stranded target DNA is present in the reaction mixture"? What if you recite "a polymerase sufficient to extend" - is it still eligible? Are there new amplification methods that don't include the steps (heating, cooling, repeating at least 20 times) or compenents (Taq, free nucleotides, two primer sequesnces) specified in claim 2? Am I missing something here? If I'm right, my fear is that some practitioners may advise clients that claims drafted consistent with claim 2 of Example E are enforceable based solely on these guidelines, when in fact they may not be.

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