Breaking the Routine: New Guidance on Patent Eligibility

I’m kind of passionate about patent eligibility. A little weird, right? I guess when a single legal doctrine has such vast implications for the value of U.S. patents, it’s not surprising that a lot of ink is spilled on its behalf. Also, it’s an ongoing battle for some of my clients.

To date, applying the patent-eligibility law has been inconsistent at best. This kind of chaos is unsettling to inventors, companies, universities, and investors. Some recent caselaw, however, has motivated me to now spill a little more ink (albeit digital ink). In particular, the Federal Circuit and the U.S. Patent and Trademark Office have provided some guidance for applying Supreme Court precedents in determining whether certain claims are patent eligible. This may be helpful to patentees and patent applicants.

Patent eligibility is governed by 35 U.S.C. §101. Claims directed to only laws of nature, natural phenomena, and abstract ideas are not patentable. This is because claims directed to these “judicial exceptions” would too broadly preempt their use in the relevant arts.[1] The Supreme Court elaborated a two-part test for patent eligibility, the so-called "Mayo Test:" (1) Determine whether the claim recites a judicial exception, and if so, (2) determine whether the claim elements, considered both individually and as an ordered combination, contain something “significantly more than the judicial exception.” The second step in the Mayo test is typically where the problems arise. What does “significantly more” mean? It means something that is not “well-understood, routine, and conventional.” So what does that mean?

This sounds a lot like the “common sense” that could be used to combine known elements in the prior art to determine that an invention is obvious.[2] In the Berkheimer case, the Federal Circuit has now told us that the standard is different:

“Whether a particular technology is well-understood, routine, and conventional goes beyond what was simply known in the prior art. The mere fact that something is disclosed in a piece of prior art, for example, does not mean it was well-understood, routine, and conventional.”[3]

Thus, under Berkheimer, it would be improper to discount a claim element that is “significantly more than the judicial exception” by simply identifying it in the prior art. One most prove that it was well-understood, routine, and conventional. For example, a single reference to the claim element in an obscure publication may not be enough.

Following the Berkheimer guidance, the Exergen case found a method of measuring body temperatures patent eligible because, while the body temperature is a natural phenomenon, and the measurement is an abstract idea, the measuring steps were not well-understood, routine, and conventional.[4]

On April 19, 2018, the USPTO released a memorandum pertaining to recent subject matter eligibility in light of Berheimer. The memo points out that claims reciting improvements over the prior art rendered the Berkheimer claims patent-eligible. It informs the examining corp. that whether something is well-understood, routine, and conventional to a skilled artisan at the time of the application is a factual determination. It states that “an examiner should conclude that an element (or combination of elements) represents well-understood, routine, conventional activity only when the examiner can readily conclude that the element(s) is widely prevalent or in common use in the relevant industry.” (Emphasis in original.) The analysis is the same as that under 35 U.S.C. §112(a) for determining whether the element is so well-known that it does not need to be described in detail in the specification. The analysis is not the same as that for patentability over the prior art under 35 U.S.C. §§102 and 103. Thus, the “something more” claim element must be very routine.

Some patent applicants have been frustrated that the examiners have arbitrarily rejected their evidence that the claim elements, individually or in an ordered combination, are not well-understood, routine, and conventional. This runs contrary to their burden of providing objective evidence and not just baseless assertions.[5] The memo, however, now provides guidance for the examiners’ burden of proof. They must rely on the following:

1. A citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates the well-understood, routine, conventional nature of the additional element(s).
2. A citation to one or more of the court decisions discussed in MPEP §2106.05(d)(II) that note the well-understood, routine, conventional nature of the additional element(s).
3. A citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element. Simply appearing in a publication is not enough. They must be so well-known that they do not need to be described in detail in a patent application under 35 U.S.C. §112.
4. A statement that the examiner is taking official notice of the well-understood, routine, conventional nature of the additional element(s). If the applicant challenges the official notice, the examiner must provide evidence as described above in paragraphs 1-3.

[1]Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (U.S. 2012); Alice Corp.; Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347, 2354 (2014).
[2]KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1742 (2007)
[3]Berkheimer v. HP Inc., 881 F.3d 1360, *1369 (Fed. Cir. 2018)
[4]Exergen Corp. v. Kaz United States, 2018 U.S.App. LEXIS 6004, *13-14 (Fed. Cir. 2018).
[5]In re Yates, 663 F.2d 1054, 1057 (CCPA 1981)

Tags: Kaplan IP Law biotechnology patent intellectual property pharmaceutical clean energyPatent eligibility, Prometheus, Mayo, Alice, Bilski, 35 USC 101, 35 U.S.C. 101, Myriad, Berkheimer