Two recent examination guidance memoranda issued by the USPTO to assist patent examiners in examination procedures highlight the importance of two recent Fed Circuit cases: Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd.[1] and Berkheimer v. HP Inc.[2] The Berkheimer memo issued on April 19, 2018, and the Vanda memo issued on June 7, 2018.
The memos were written to assist patent examiners during prosecution of applications with claims that raise patent eligibility issues under 35 U.S.C. §101, and provides guidance as to how to handle rejections. Specifically, the Vanda memo is directed to Step 2A of the Alice test’s analysis, while the Berkheimer memo is directed to Step 2B of that analysis.
Step 2A of the Alice test for subject-matter eligibility requires determining whether the claims are directed to a judicial exception. Vanda held that claims reciting a method for treating schizophrenia with the drug iloperidone through specific dosage administrations was not directed to a judicial exception because it claimed an application of a natural phenomenon (i.e., a judicial exception), rather than being directed to a natural phenomenon itself. Therefore, the claims were patent-eligible under §101. The Vanda memo raised three points to guide examiners:
- Claims should be evaluated as a whole to determine whether they are directed to a judicial exception;
- Methods of treatment claims, which apply natural relationships rather than merely are directed to them, would not be deemed to fall under a judicial exception; and
- Because the Vanda claims were determined to not be directed to a judicial exception under Step 2A, and therefore, the claims were patent-eligible, a Step 2B analysis is not necessary to determine whether the recited steps are “routine or conventional.”.
Step 2B of the Alice test requires the claim recite additional elements to amount to “significantly more” than the judicial exception. One aspect to determining whether the additional elements amount to “significantly more” is whether they are “well-understood, routine, or conventional” to a person of ordinary skill in the art (i.e., POSITA). Berkheimer held that determining whether certain claim limitations are well-understood, routine, or conventional is a question of fact. The Berkheimer memo revises a portion of MPEP 2106 to direct examiners on determining whether a claim element is not well-understood, routine, or conventional, to expressly support the §101 rejection with one or more of the following:
- A citation to an express statement in the specification or applicant’s admission (MPEP 2129) that the element is “well-understood, routine, or conventional”;
- A citation to one or more court decisions listed in MPEP 2106.05(d)(II) illustrating what is “well-understood, routine, or conventional’;
- A citation to a publication that demonstrates “well-understood, routine, or conventional” (MPEP 2128), although it may not necessarily be a prior art under 35 U.S.C. §102, but the publication should demonstrate the element is so “well-understood, routine, or conventional” in that field that it does not need to meet the requirements under 35 U.S.C. §112(a); or
- Official notice that an element that is “well-understood, routine, or conventional” (MPEP 2144.03).
[1] 887 F.3d 1117 (Fed. Cir. 2018), aff’g Vanda Pharm. Inc. v. Roxane Labs, Inc., 203 F. Supp. 3d 412 (D. Del. 2016).
[2] 881 F.3d 1360 (Fed. Cir. 2018), aff’g-in-part, vacating-in-part, and remanding, Berkheimer v. Hewlett-Packard Co., 2015 WL 4999954 (N.D. Ill. Aug. 21, 2015), en banc rehearing denied, ___F.3d___ (Fed. Cir. 2018).