USPTO Issues Preliminary Guidance on Mayo v. Prometheus

By Donald Zuhn --

One day after the Supreme Court reversed the Federal Circuit in Mayo Collaborative Services v. Prometheus Laboratories, Inc., finding Prometheus' diagnostic method claims to be invalid for "effectively claim[ing] underlying laws of nature," the U.S. Patent and Trademark Office issued a memorandum to its examining corps providing the Office's preliminary guidance regarding the High Court's decision.  The three-page memo, sent by Associate Commissioner for Patent Examination Policy Andrew Hirshfeld, notes that the guidance provided is preliminary and that "[a]dditional guidance on patent subject matter eligibility under 35 U.S.C. § 101 will be issued soon."

Under the heading "Claims to Law of Nature Itself Are Not Patent-Eligible," the memo begins by reciting claim 1 of Prometheus' U.S. Patent No. 6,355,623.  In summarizing the Court's decision, the memo states that:

The Supreme Court found that because the laws of nature recited by the patent claims -- the relationships between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage will prove ineffective or cause harm -- are not themselves patent-eligible, the claimed processes are likewise not patent-eligible unless they have additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations.  The additional steps in the claimed processes here are not themselves natural laws, but neither are they sufficient to transform the nature of the claims.

In this case, the claims inform a relevant audience about certain laws of nature.  Any additional steps consist of well-understood, routine, conventional activity already engaged in by the scientific community.  Those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.  The Court has made clear that to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words "apply it."  Essentially, appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patent-eligible.

(emphasis in original).

In a second part of the memo, the Office lays out its preliminary guidance regarding examination procedure in light of the Court's decision.  The memo notes that "examiners should continue to examine patent applications for compliance with section 101 using the existing Interim Bilski Guidance" along with some additional considerations set out in the memo.  In particular, the memo states that:

Examiners must continue to ensure that claims, particularly process claims, are not directed to an exception to eligibility such that the claim amounts to a monopoly on the law of nature, natural phenomenon, or abstract idea itself.  In addition, to be patent-eligible, a claim that includes an exception should include other elements or combination of elements such that, in practice, the claimed product or process amounts to significantly more than a law of nature, a natural phenomenon, or an abstract idea with conventional steps specified at a high level of generality appended thereto.

(emphasis in original).

The memo advises examiners to reject claims that are "effectively directed to the exception itself (a law of nature, a natural phenomenon, or an abstract idea)" as being directed to non-statutory subject matter, and provide applicants with an opportunity "to explain why the claim is not drawn solely to the exception and point to limitations in the claim that apply the law of nature, natural phenomena or abstract idea."

The memo concludes by noting that the Office continues to study the Supreme Court's decision in Mayo, and is "developing further detailed guidance on patent subject matter eligibility under 35 U.S.C. § 101."

For additional information regarding this topic, please see:

• "Mayo Collaborative Services v. Prometheus Laboratories -- What Should We Do? (or Can These Claims Be Saved?)," March 26, 2012
• "Mayo Collaborative Services v. Prometheus Laboratories -- What the Court's Decision Means," March 22, 2012
• "Mayo Collaborative Services v. Prometheus Laboratories -- What the Supreme Court Said," March 21, 2012
• "Early Reaction to Supreme Court Decision in Mayo v. Prometheus," March 20, 2012
• "Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012)," March 20, 2012
• "Deciphering the Patent-Eligibility Message in Prometheus, Myriad and Classen," March 20, 2011

Comments

[Skeptical]

Someone acting in a legal capacity should know how to give proper credit. Citations should be made when one lifts whole sections from someone else's work.

[EG]

"In addition, to be patent-eligible, a claim that includes an exception should include other elements or combination of elements such that, in practice, the claimed product or process amounts to significantly more than a law of nature, a natural phenomenon, or an abstract idea with conventional steps specified at a high level of generality appended thereto."

Don,

The Examining Corps, as well as prosecuting patent attorneys are going to have an Excedrin-sized headache trying to carry out that suggestion. That's what happens when you have the Supreme Court ignore or conveniently overlook binding precedent in Diehr that says do the exact opposite (and rightly so).

[Anne Barschall]

It would be helpful if you would post the exact claim language from the case in this notice.

[6]

Meh, not really EG. It usually isn't that hard unless a %$#% drafted the thing. Which does happen from time to time of course, but you know how it goes. Those cases will be a headache anyway.

[Donald Zuhn]

Anne:

Sorry, I omitted the text of the claim because Kevin had provided it several times over the past week. Here is claim 1:

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and


(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,


wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and


wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

Thanks for reading,

Don

[6]

Not gonna help Don.

[Seth]

So... would this fly?

1. A method of treatment of an immune-mediated gastrointestinal disorder, the method comprising administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder in an amount sufficient to provide a level of 6-thioguanine greater than about 400 pmol per 8x10^8 red blood cells and less than about 1 nmol per 8x10^8 red blood cells in the bloodstream of said subject.

Why, or why not?