Ex parte Kotanko (PTAB 2018)

By Donald Zuhn –-

In an interesting decision issued last year, the Patent Trial and Appeal Board reversed the final rejection of claims 1-5 and 9 in U.S. Application No. 12/959,017.  The claims at issue had been rejected under 35 U.S.C. § 101 as reciting patent ineligible subject matter in the form of an abstract idea, and under 35 U.S.C. § 103(a) as being unpatentable over U.S. Patent No. 6,454,707 and U.S. Patent Application Publication Nos. US 2006/0226079 A1 and US 2009/0082684 A1.  This post addresses the Board's reversal of the § 101 rejection.

The '017 application relates to the identification of a patient undergoing hemodialysis treatments at increased risk for death.  Representative claim 1 recites:

1.  A method of identifying and treating a patient undergoing periodic hemodialysis treatments at increased risk for death, comprising:
    a) determining at least one clinical or biochemical parameter associated with an increased risk of death of the patient and monitoring said parameter periodically before and/or after the patient is undergoing hemodialysis treatments;
    b) determining a significant change in the rate of change of the at least one clinical or biochemical parameter from a retrospective record review of parameter values of the patient determined at prior hemodialysis treatments;
    c) identifying the patient as having an increased risk for death because the patient has the significant change in the rate of change of the at least one clinical or biochemical parameter; and
    d) treating the patient having an increased risk for death within a sufficient lead time to decrease the patient's risk of death.

In reversing the § 101 rejection, the Board began by noting that it was "persuaded by Appellants' arguments that the claimed method is not an abstract idea, because the claims 'have the particular practical application of identifying a patient as having an increased risk of death and treating the patient to decrease the risk of death.'"  The Board also noted that the Examiner's rejection of claim 1 was based on the finding that steps a) to c) can be performed with mental thought alone, and that treating step d) is not a "transformation of a patient" because "the treatment step can be anything; i.e. not necessarily having to do with hemodialysis."  In the Examiner's Answer, the Examiner concluded that "the claim is effectively [directed] to the general correlation and the abstract idea of doing the significant change analysis."

The Board, however, disagreed with the Examiner, stating that:

Although the claim includes steps that can be performed mentally, "treating the patient . . . to decrease the patient's risk of death" is not a phenomenon of nature, mental process, or abstract intellectual concept.  This is a specific type of treatment, as opposed to, for example, treating only to alleviate pain.  The claim as a whole is directed to more than just steps capable of being performed mentally.

The Board explained that "the claim, considered as a whole, is not directed merely to an abstract idea, as defined under step one of the Alice analysis, because it includes treating a patient to reduce a risk of death."  Citing Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347, 2359 (2014), the Board also suggested that "if one were to consider the claim under the second step of the Alice analysis, the treatment of a patient to reduce the risk of death functions to 'effect an improvement in [another] technology or technical field,' namely medicine."

The Board therefore refused to sustain the rejection of claim 1 (or dependent claims 2-5 and 9) under § 101.  After also refusing to sustain the rejection of claims 1-5 and 9 under § 103, the Board reversed the rejection of claims 1-5 and 9 under §§ 101 and 103.

Following the Board's Decision on Appeal on March 20, 2017, a Notice of Allowance was mailed on June 8, 2017.  A Request for Continued Examination and Information Disclosure Statement was filed on August 31, 2017, and a second Notice of Allowance was mailed on September 20, 2017.  The '017 application issued as U.S. Patent No. 9,883,799 on February 6, 2018.

Ex parte Kotanko (PTAB 2018)
Panel: Administrative Patent Judges Crawford, Fischetti, and Kim
Decision on Appeal by Administrative Patent Judge Crawford

Comments

[Atari Man]

Wow, a bit of sanity from the PTAB. I guess statistically these things have to happen every so often...just wish it was in MY clients' favor.

[Suzannah]

Nice to see that PTAB didn't do some type of song and dance about the treatment step being well-understood, routine, or conventional to find that it does not add anything significantly more and thereby find the claim ineligible.

[skeptical]

Cringe worthy:

"This is a specific type of treatment, as opposed to, for example, treating only to alleviate pain."

alleviation of pain (physical pain, one may presume) can be every bit as "specific" as treatments to "decrease risk of death," and in fact may be MORE specific, given that "risk" in the "risk of death" may be indicative merely of a probability that does not actually manifest.

Before I "cheer" on this decision as a "victory," I must first wade through the slime that the Supreme Court has made of 101.

[AAA JJ]

"Although the claim includes steps that can be performed mentally, 'treating the patient . . . to decrease the patient's risk of death' is not a phenomenon of nature, mental process, or abstract intellectual concept. This is a specific type of treatment, as opposed to, for example, treating only to alleviate pain. The claim as a whole is directed to more than just steps capable of being performed mentally."

So "treating a patient to decrease the risk of death" is NOT abstract, but treating a patient to alleviate pain is abstract?

That's some interesting "logic" to be sure.

[Stare Decisis]

To advance clarity overall in biotech, more PTAB decisions (and, more importantly, precedential CAFC decisions) are needed addressing biotech claims such as this one. So this decision is at least interesting from that standpoint, but it raises some questions.

First, if a general "treating the patient" step can provide a non-conventional additional element to satisfy 101, then most any physical step or element could be asserted as doing the same for any claim otherwise directed to an abstract idea, which would effectively nullify the otherwise still controlling judicial exceptions for all but the most thoroughly abstract claims. By not analyzing "conventionality" of the treatment step (i.e. whether that step is routine and well-known and thus does not add significantly to the claim), it is not clear how the decision is consistent with Alice and later precedential CAFC opinions, which do undertake such an analysis (e.g. the conventional computer elements of Alice). It's one thing if case law is moving to a much more 101-liberal, "In re Abele" standard, but that would seem to be for the CAFC to decide. Instead, at the very least here, a more careful analysis of conventionality would have been helpful, consistent with presently controlling, post-Alice, CAFC opinions. Also, on a related point, the panel here first addressed 101, then 103. The analysis of conventionality, while using a different threshold, less limiting regarding patentability, (i.e. looking to routine and well-known art re 101 instead of looking to any obviously combinable art for 103), nonetheless can be informed by looking for evidence to the same art that enters the 103 analysis, if that art is routine and well-known. (Thus, satisfying 103 because of an additional element also typically means that element is non-conventional.) A decision without a careful analysis of art representative of the previous state of the technology field and explanation in that regard is difficult to reconcile with post-Alice case law.

Second, and similarly, if it is to be an improvement argument that is dispositive, more analysis and explanation again would be helpful. Any applicant or patent owner can assert "an improvement," so clearly there must be some threshold in that regard, and here there appears to be little analysis as to whether any threshold has been met regarding improvement.

Of course, a significant part of the miscommunication and the diversity of opinions in this area appears to be that various parties are using different analyses, as disparately distilled from the varied case law.

[Paul F. Morgan]

If "determining at least one clinical or biochemical parameter associated with an increased risk of death of the patient" includes noticing that the patient has stopped breathing [or anything else], one can wonder why there was not a 112 claim breadth issue here?

[Joe Barrera]

I must be an outlier. ok a claim to practice medicine, and care for patients, is not abstract? What am I missing? ok. lets say you have a good patent claim, who do you enforce this against? A medical school professor who teaches his students to monitor such parameters, or the doctor, a hospital for instructing the nurse or doctor to monitor such parameters? What have you created, and what are you selling?

[Maybe I'm amazed]

So no-one sees a preemption problem here? WOW! Almost as amazing is no 103 could be maintained? Seems even the Applicant was uncomfortable with accepting this allowance, as they filed an RCE to narrow the claims before accepting allowance?

[Cheryl R. Figlin]

I also wonder about other outcomes besides death. For example, what if the treatment is to cure a non-deadly disease or alleviate a horrible symptom...would it get the same analysis?

[Jim Demers]

The one and only non-trivial operation in the claimed method is "determining a significant change in the rate of change" of some parameter. (Plotting the parameter over time, this is the second derivative of the line - i.e., the curvature.
In other words, if the line starts to curve (upward or downward), do something about it. (And mail in a royalty check?) This is how you'd react to any relevant parameter, for any patient, with any disease. How does this survive §103?

[Stare Decisis]

And I have to agree with “Maybe I’m amazed” and Paul Morgan — surely there should be 101 questions regarding preemption and probably also 112 regarding breadth and even 103 questions regarding scope.

Does “at least one clinical or biochemical parameter” not read on the patient’s WEIGHT?

What if weight was constant but later began changing, doesn’t “determining a significant change in the rate of change of the at least one clinical or biochemical parameter” read on gain or loss of WEIGHT? Can’t weight gain be “associated with an increased risk of death”? Isn’t there art on standard of care regarding medical professionals monitoring weight gain or loss of a hemodialysis patient? Of all patients?

Is there any difference between a “RETROSPECTIVE record REVIEW of parameter values” and merely a “record REVIEW of parameter values”? Aren’t all “REVIEWS” already “RETROSPECTIVE”? That sounds like one of several 112(b) issues, regarding redundant language and regarding “retrospective” as a relative term — years, months, days, minutes?

And why “determining a significant CHANGE IN THE RATE OF CHANGE of the at least one clinical or biochemical parameter”? Second derivative? Acceleration? Is that really what’s intended / supported? And, in any case, that still reads on a change from constant (zero change) to changing, which is the typical medical condition, i.e. departure from homeostasis. It’s just an unnecessarily complicated way of reciting the limitation, again causing the claim to be subtly broad.

At least the examiner was not allowing this claim, until...

[Martin Snyder]

The inability of the system to have a safety valve to tank this claim nine different ways from Sunday is why the baby of good inventions goes out with the bathwater of rubbish like this.

These claims cover the entire practice of medicine as been done since time immemorial, only limited to the entire subject matter of hemodialysis. There is not a hint of invention within.

Once issued, this patent will be destroyed in litigation if asserted, and more of society's resources will be wasted on a broken legal game.

Nobody should be happy about this.