Biotech-specific Subject Matter Eligibility Materials Delayed

By Kevin E. Noonan --

Pursuant to the Notice published in the Federal Register today, the U.S. Patent and Trademark Office provided additional materials related to the Office's interpretation of what does (and what does not) satisfy the subject matter eligibility requirement of 35 U.S.C. § 101 (as interpreted by the Supreme Court).  What was not made available were materials related to interpreting the metes and bounds of the statute with regard to natural products or diagnostic methods.  Instead the Office provided the three Appendices referenced in the Notice directed to the effects of the Supreme Court's Alice v. CLS Bank decision.

Appendix 1 sets forth seven additional examples (in excess of the twenty previously set forth by the Office) related to Alice-type claims.  These include examples taken from Parker v. Flook and Diamond v. Diehr as well as hypothetical examples and cases decided in the inferior courts.

Appendix 2 is a comprehensive index of all 27 of the Examples from the Office, set forth in tabular form for ease of appreciation of how the Office is making its decisions.

Appendix 3 has some relevance to the biotech and diagnostic methods audience, which lists nine Supreme Court decisions and thirty-six Federal Circuit and CCPA decisions related to subject matter eligibility.

PTO sources indicate that the expected biotech and diagnostic methods materials are still in process and are expected to be put up on the PTO website in future.  The extent to which there may be internal dissension regarding such materials, or the effect of Drew Hirschfield's ascension to be Commissioner of Patents on this delay are unknown.

Patent Docs plans to provide additional information regarding the examples of Appendices 1 and 2 in subsequent posts.

Comments

[Diana Cox]

Sorry for the long bloviation - I didn't have time to make it shorter.

I have been trying to get feedback from examiners on an argument I have been making regarding preemption in diagnostic cases, which has essentially been ignored, and I was looking for some clarification from the Updated Guidance, which is sadly obtuse on the topic, from what I understand after a first pass.

The essence of the argument: when a diagnostic claim that recites detecting and quantitating an analyte (and then doing a statistical analysis on the result, including correlating with predetermined amounts that are diagnostic/prognostic/theranostic [the "natural law"]) specifies with some degree of particularity the type of assay that is used to detect and quantify, that claim INHERENTLY does not preempt the use of the natural law by anyone else who uses a different method of detecting and quantitating the analyte - and thus the natural law cannot be preempted, because others can detect it using other analytical techniques.

That type of claim is clearly distinguished from the claims in Mayo, which encompassed ANY method of measuring the drug metabolites.

I am not understanding why the CAFC said (in Ariosa) and USPTO is parrotting, that:

"The Supreme Court has made clear that the principle of preemption is the basis for the judicial exceptions to patentability. Alice, 134 S. Ct at 2354 (“We have described the concern that drives this exclusionary principal as one of pre-emption”). For this reason, questions on preemption are inherent in and resolved by the § 101 analysis. The concern is that “patent law not inhibit further discovery by improperly tying up the future use of these building blocks of human ingenuity.” Id. (internal quotations omitted). In other words, patent claims should not prevent the use of the basic building blocks of technology—abstract ideas, naturally occurring phenomena, and natural laws. While preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility. In this case, Sequenom’s attempt to limit the breadth of the claims by showing alternative uses of cffDNA outside of the scope of the claims does not change the conclusion that the claims are directed to patent ineligible subject matter. Where a patent’s claims are deemed only to disclose patent ineligible subject matter under the Mayo framework, as they are in this case, preemption concerns are fully addressed and made moot.

Sequenom and amici encourage us to draw distinctions among natural phenomena based on whether or not they will interfere significantly with innovation in other fields now or in the future. The Supreme Court cases, however, have not distinguished among different laws of nature or natural phenomenon according to whether or not the principles they embody are sufficiently narrow."

Did you see that little non-sequitur in there?
"While preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility."

Why is this even in the decision? It is unnecessary to the conclusion in Ariosa - Sequenom was arguing that the ANALYTE had other uses (which doesn't even make sense to me in context - why did they not argue that there were other method of detection of the cffDNA, and they were only claiming their novel method of detection?) - not only is the Ariosa decision wrong, this is utterly off-point dicta.

And yet, the Updated Guidance repeats it:
"The Supreme Court has described the concern driving the judicial exceptions as preemption,26 however, the courts do not use preemption as a stand‐alone test for eligibility.27"

Both the Ariosa case and the Update cite Flook for this principle - yet the claims in Flook were actually completely preemptive of the use of its mathematical formula, albeit in a narrow field - in fact, the claim was arguably directed to the result of the calculation itself (the alarm limit – a number). The claims in Flook were nothing like the claims in Ariosa; the use of the Flook formula in the field of catalytic converter reactors was preemptive; and in Flook, the inventor expressly conceded that the implementation of the result was conventional.

Thus, I don't understand why this strange holding in Ariosa, that lack of preemption is not enough, which isn't even directly relevant to what was argued by Sequenom, and which cites Flook which doesn't even SAY that, is being cited in the Update without context, as if it is some well-settled guiding principle, and thus preventing a clear LACK of preemption (when there are other ways of measuring the analyte) which should meet the conditions of the Streamlined Analysis, from being the end of the inquiry for diagnostic claims - when the entire reason for these "judicial exceptions" is concerns about preemption in the first place!

The inventor who discovers a natural law should be rewarded for it, without being given complete preemption over ALL uses of the natural law. Thus, discovering that an analyte not previously known to be a marker for a disease, or identifying the level that is diagnostic for it, is promoting the progress of science. A reasonable reward would be, e.g., a practical and enforceable claim to a method for diagnosing the disease by measuring the analyte using a particular assay, and comparing it to threshold values the inventor discovered (using the claimed type of assay), and thus should be allowed, as it doesn't preempt other ways of using the natural law, or even the threshold numbers themselves, even if the claimed method is the most commercially relevant one (at the time the invention is made). Most importantly, that invention directly to a method of using a natural law via a specific assay should stimulate further invention to find a better commercially relevant assay – and isn’t that the policy behind patent law in the first place?

I wonder if there will be a biotech/diagnostic Example that fits the lack of preemption facts found in the (non-biotech/diagnostic) PTAB case In re Schmid et al.?

[Skeptical]

Sadly Diana, I do not think your logic is "sound" in light of what the Supreme Court did in the Prometheus case.

Recall there that the Court sharpened its "Gist/Abstract" sword by reaching into the future and inserting the notion that "a test" could be invented - and such test properly differentiating as different enough to earn a patent on its own - had NO effect on the "Court-stripped" gist of the claim.

Your argument then fails because you are attempting a distinction that does not make a difference to what the Court decided. You do not in fact distinguish from Prometheus because the decision of Prometheus is wider than than your subset, and includes your subset argument.

Think of the Court's "future" reasoning as an "or" type of reasoning rather than an "and" type of reasoning. The Court did not rest on what the claim means as understood by a Person Having Ordinary Skill In the Art - today. The Court even "gisted" away the very claim element of HAVING a test as a claim element. Read again their words: they passed judgment NOT on the claim as written, with all elements, but as the claim was "gisted" to be, what they felt that the "invention was to."

Let me also point out that your "future building blocks" quote is itself critically parsed - you left out the "may" conjectural tone. As we may yet see [pun intended], this forward looking aspect shows a violation of authority of the Court against mere advisory opinions (a new study tends to confirm that no such "danger" has been shown - and may never arise).

Further, the Office must distance itself from a too-strong view on pre-emption. It is abundantly clear that ALL claims - by their very nature - pre-empt. That is what they are intended to do.

Whether or not this "common sense" view of patents percolates enough to overcome the clear desire of ends-based "Justice," well, I still remain...