By Kevin E. Noonan --
On May 4th the U.S. Patent and Trademark Office issued its latest Guidance on how Examiners are to apply recent U.S. Supreme Court and Federal Circuit precedent related to subject matter eligibility (see "USPTO Issues Update to Subject Matter Eligibility Guidance"). Absent from this analysis was the Federal Circuit's decision in Ariosa v. Sequenom, then on petition for certiorari before the Supreme Court. Since the issue date of this Guidance, the Supreme Court denied certiorari in the Sequenom case, and the Federal Circuit handed down its decision in Rapid Litigation Management v. CellzDirect. Last Friday, the Office issued a Memorandum on these decisions.
The Memorandum, under Deputy Commissioner for Patent Examination Policy Robert Bahr's signature, comes right to the point:
These cases do not change the subject matter eligibility framework, and the USPTO's current subject matter eligibility guidance and training examples are consistent with these cases.
and then discusses each case and its relationship to how the PTO will implement the recent case law.
With regard to CellzDirect, the Memorandum cites the Federal Circuit decision as "highlight[ing] several important points." The first is the Court's emphasis on whether a claim is "directed to" a law of nature, which "requires more than 'merely identify[ing] a patent-ineligible concept underlying the claim.'" Rather, the Office understands the CellzDirect decision to require "an analysis of whether 'the end result of the process, the essence of the whole, was a patent-ineligible concept.'" By focusing on "a process for achieving this desired outcome," according to the Memorandum, the Federal Circuit concluded the claims at issue were patent eligible, "like thousands of other claims that recite methods of producing things [the mixed cultures of hepatocytes that were the subject of the claims] or methods of treating disease" (a welcome extrapolation of the Federal Circuit's decision but an extrapolation just the same and one not supported expressly by the Court's decision). The Memorandum also referenced the Federal Circuit's Enfish decision, and asserts that the distinction between the CellzDirect decision and the Sequenom and Supreme Court's Mayo decision was that the latter decisions "amounted to nothing more than observing or identifying the ineligible concept itself." This section of the Memorandum concludes with the statement that "[t]he USPTO's current subject matter eligibility guidance [set out in the 2014 Interim Eligibility Guidance, July 2015 Update, and the May 2016 Update memoranda to examiners] and training examples are consistent with these points."
Turning to the denial of certiorari in the Sequenom case, the Memorandum is succinct: its Guidance was consistent with the Federal Circuit's decision, and denial of Sequenom's certiorari petition changes nothing ("While this panel decision is a precedential Federal Circuit panel decision, the denial of the petition for a writ of certiorari does not elevate its significance in this regard"). While true, this statement does not resolve the apparent conflict between the Federal Circuit's affirmance that Sequenom's claim 1:
1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises
amplifying a paternally inherited nucleic acid from the serum or plasma sample and
detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.
is patent ineligible, with the Guidance's treatment of claim 1 of Example 29
1. A method of detecting JUL-1 in a patient, said method comprising:
a. obtaining a plasma sample from a human patient; and
b. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody.
to be patent eligible. The Federal Circuit reasoned in Sequenom that:
It is undisputed that the existence of cffDNA in maternal blood is a natural phenomenon. Sequenom does not contend that Drs. Lo and Wainscoat created or altered any of the genetic information encoded in the cffDNA, and it is undisputed that the location of the nucleic acids existed in nature before Drs. Lo and Wainscoat found them. The method ends with paternally inherited cffDNA, which is also a natural phenomenon. The method therefore begins and ends with a natural phenomenon. Thus, the claims are directed to matter that is naturally occurring.
While the Office provides the following reasoning regarding claim 1 of Example 29:
[C]laim 1 is eligible because steps (a) and (b) of the claim "do not recite or describe any recognized exception" [the example cites Mayo Collaborative Services v. Prometheus Laboratories, Inc. in support of this determination, which the example indicates stands for the proposition that the recited steps of administering a drug to a patient and determining the resultant level of 6-thioguanine in the patient "are not themselves natural laws"]. As a result, the analysis of this claim ends with Step 2A of analytic framework set forth in the Interim Guidance (i.e., determining whether the claim is directed to a judicial exception), and the example notes that there is no need to proceed with Step 2B of the analytic framework (i.e., determining whether any element, or combination of elements, in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exception).
The extent to which these disparate analyses can be reconciled will depend, of course, on future case law, leaving the question of subject matter eligibility in its current state of uncertainty.
Also still incomprehensible to me: how in Claim 2 of Example 29, adding step (c) to the language of Claim 1 renders the claim ineligible. (Step (c) being "diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected.") I wonder if the analysis of claim 1 is somehow being thrown off by the presence in the hypothetical of novel antibodies and the statement that prior to the invention, porcine antibodies "were not routinely or conventionally used to detect human proteins such as JUL-1." But that still would not explain how claim 2 becomes ineligible when a step is added.
Posted by: Garrett | July 19, 2016 at 09:12 AM
I am so glad that the Office folded in Bascom to their memo.
Oh, wait....
;-)
Posted by: skeptical | July 19, 2016 at 02:49 PM
Garrett:
It isn't logical and it isn't supposed to be. The Office has taken the position that the novelty of the method rescues it from Sec. 101 invalidity, except when the Supreme Court has expressly held that it does not. Now, I think there are better ways to distinguish these cases, but so long as the PTO believes (as does the CAFC) that their hands are tied, and the Supreme Court is unwilling to revisit the issue, this is the best we are going to get (at least in the Office).
Which is better than nothing.
Thanks for the comment.
Posted by: Kevin E Noonan | July 19, 2016 at 04:33 PM
Dr. Noonan,
I disagree with a "fait accompli, we have to take this because it is better than nothing" approach or mindset.
One does not throw a big juicy steak to the wolf at the back door "because it is better than nothing."
Posted by: skeptical | July 19, 2016 at 07:18 PM
Thanks, Kevin.
Also I'm wondering if the claim analysis in Bascom (essentially considering the claim as a whole?) signals a retreat from the approach we had seen in some earlier cases pulling the claim apart and analyzing each limitation separately. But maybe now a court can choose to consider the claim as a whole (if they wish to deem it valid) or not (if they wish to invalidate it), with appropriate citations for either approach.
Posted by: Garrett | July 20, 2016 at 08:05 AM
I think the point with claim 2 is that it adds in a new judicial exception, the abstract idea, and that for whatever reason, the claim then becomes "as a whole" directed to that judicial exception without reciting "significantly more." Claim 1 is not considered "directed to" the natural phenomena judicial exception. It's a bit of handwaving but the office's rationale helps explain their logic, if shaky at least its followable.
Posted by: PatentAnon | July 20, 2016 at 08:36 AM
"I'm wondering if the claim analysis in Bascom (essentially considering the claim as a whole?) signals a retreat from the approach we had seen in some earlier cases pulling the claim apart and analyzing each limitation separately."
I think what it indicates is that one's outcome in a CAFC § 101 case is very panel dependent. I do not doubt for a moment that if Judge Dyk had been on the Bascom panel, then we would have seen a great deal more dissection (at least in a concurrence or dissent). Basically, by this point if a judge wants to dissect, there is precedent to support that approach (BRCA1 Cancer Test, Sequenom, etc) and if one wants not to dissect, there is precedent to support that (Bascom, CellzDirect, etc).
It all comes down to what the judges on a given panel want to do. This is a crummy way to run a system of laws, but at least for the moment it is what we get.
Posted by: GrzeszDeL | July 20, 2016 at 10:12 AM
Ugh,
More "but that's what we got."
Accepting "what we got" is just not acceptable.
Posted by: skeptical | July 20, 2016 at 11:21 AM