The Alice/Mayo test for patent eligibility of US patents and applications has been a cause for concern in recent years, particularly in the sphere of software and diagnostics inventions. The decision in Berkheimer may offer some relief in those particular fields, as it would seem to limit the scope of the second step (“Step 2B”) of the Alice/Mayo test. This might provide proprietors of software and diagnostics inventions with a fighting chance of making it past the patent eligibility test.
Following the landmark decisions of Alice and Mayo by the Supreme Court of the United States, the US Patent Office (USPTO) substantially raised the bar on what constituted “patent eligible subject matter”. In brief, the above decisions significantly increased the difficulty of being able to patent software-based inventions and diagnostics inventions in the US. The rationale behind this was essentially that software-based inventions were “abstract ideas” and diagnostics inventions were “a law of nature”, both of which (abstract idea and law of nature) are excluded from patentability under the US statute 35 USC §101.
In order to show that an invention is “patent eligible” (under the current system that was developed following Alice and Mayo) it is necessary to satisfy a three-step test. Step 1 asks “is the claim to a process, machine, manufacture or composition of matter?” Considering that most inventions will relate to at least one of these categories this step is easy to satisfy, so the next step 2A must be considered. Step 2A asks “Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (these are commonly known as the “judicial exceptions” to patentability)?” If the answer is no then the claim is patent eligible. However, if the answer is yes then it is necessary to consider Step 2B, which asks “Does the claim recite additional elements that amount to significantly more than the judicial exception?” This, in part, requires determining whether the additional elements recited in the claim are more than elements that are “well-understood, routine, or conventional in nature”. If yes, then the claim is patent eligible, however if the answer is no then the claim is rejected for being patent ineligible.
In the interim few years since the issuance of those decisions there have been numerous court cases wherein the issues of what is meant by “directed to a [judicial exception]” and “significantly more than the judicial exception” were considered. Unfortunately, those decisions tended to be specific to the cases at hand and did not give much insight into what may or may not be considered “patent eligible” in a more general sense. This created a significant degree of uncertainty in the software and diagnostic fields of invention, as it was not possible to predict with any certainty whether a patent would likely be granted for the claimed subject matter. Even if the subject matter was granted by the USPTO, there remained a significant chance that, if opposed by a third party, the patent might be revoked by the courts for being directed to patent ineligible subject matter.
One of the key issues, as noted above, is the question of whether the claim recites “additional elements that amount to significantly more than the judicial exception.” Numerous US patent examiners and US courts were finding that software-based inventions and diagnostic inventions were patent ineligible, as the steps involved were “well-understood, routine, or of a conventional nature” and thus did not “recite additional elements that amount to significantly more than the judicial exception.”
The underlying reasoning for these findings seems to be due to the broad application of the term “well-understood, routine, or conventional”. Take, for example, a diagnostic claim that measured a previously unknown biomarker using an immunoassay that was found to be linked to a specific disease. A patent examiner could (and in most cases would) find that such a claim was patent ineligible. The reasoning was that the claim was directed to a law of nature (Step 2A: Yes; the “law of nature” being the natural correlation between the biomarker and the disease) and that the “additional elements” did not amount to “significantly more” because the method for measuring the new biomarker was “well-understood, routine, or conventional” (i.e. it was known in the art how to develop an immunoassay once the biomarker was known, hence “well-understood, routine, or conventional” – Step 2B: No).
This, of course, blurs the lines between patent eligibility (which asks if the invention is directed to a real “thing”, i.e. a process, machine, manufacture or composition of matter) and patentability (which asks if the “thing” is new and inventive over what was known before).
The recent decision in Berkheimer v. HP Inc. (“Berkheimer”), which concerned a software-based patent, seems to be an attempt to draw a distinction between patent eligibility and patentability. Specifically, the decision in Berkheimer sets out a number of criterion that ought to be considered (and which ought not to be considered) when evaluating whether the elements in a claim amount to significantly more than the judicial exception. Following this decision, the USPTO issued a memorandum (19 April 2018) and examiner training material that takes into account the decision in Berkheimer.
The memorandum sets out the following test that an examiner must satisfy in order to find that the claimed elements are “well-understood, routine, or conventional.”
In a step 2B analysis, an additional element (or combination of elements) is not well-understood, routine or conventional unless the examiner finds, and expressly supports a rejection in writing with, one or more of the following:
- 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). A specification demonstrates the well-understood, routine, conventional nature of additional elements when it describes the additional elements as well-understood or routine or conventional (or an equivalent term), as a commercially available product, or in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a). A finding that an element is well-understood, routine, or conventional cannot be based only on the fact that the specification is silent with respect to describing such element.
- A citation to one or more of the court decisions discussed in MPEP § 2106.05(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s).
- A citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s). An appropriate publication could include a book, manual, review article, or other source that describes the state of the art and discusses what is well-known and in common use in the relevant industry. It does not include all items that might otherwise qualify as a "printed publication" as used in 35 U.S.C. § 102.3 Whether something is disclosed in a document that is considered a "printed publication" under 3 5 U.S. C § 102 is a distinct inquiry from whether something is well-known, routine, conventional activity. A document may be a printed publication but still fail to establish that something it describes is well-understood, routine, conventional activity. See Exergen Corp., 2018 WL 1193529, at *4 (the single copy of a thesis written in German and located in a German university library considered to be a "printed publication" in Hall "would not suffice to establish that something is 'well-understood, routine, and conventional activity previously engaged in by scientists who work in the field'"). The nature of the publication and the description of the additional elements in the publication would need to demonstrate that the additional elements are widely prevalent or in common use in the relevant field, comparable to the types of activity or elements that are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a). For example, while U.S. patents and published applications are publications, merely finding the additional element in a single patent or published application would not be sufficient to demonstrate that the additional element is well-understood, routine, conventional, unless the patent or published application demonstrates that the additional element are widely prevalent or in common use in the relevant field.
- A statement that the examiner is taking official notice of the well-understood, routine, conventional nature of the additional element(s).
In brief, steps 1 and 2 of the memorandum cover the instance where the applicant has admitted in the application that the claimed element is a well-known element or where the courts have found the specific element to be well-known, routine or conventional. If the application provides such an admission, or if the courts have made such a finding, then the examiner may find the element in question to be “well-understood, routine, or conventional.”
However, in our experience pre-Berkheimer, most of the “well-understood, routine, or conventional” rejections would arise as a result of the examiner finding a document that discloses the recited element (albeit in a non-identical setting). In those situations, the examiner would usually consider that the element was “well-understood, routine, or conventional” because it had been disclosed previously.
Berkheimer has challenged this interpretation. According to Berkheimer and the subsequent USPTO memorandum (step 3), such a finding may no longer be acceptable for rejecting a claim on the ground that the additional element(s) is (are) “well-understood, routine, or conventional.” Rather, it is necessary for the examiner to demonstrate that the recited elements were “well-understood, routine, or conventional” by citing review articles, textbooks, or the like. This is more akin to the standard for determining whether or not an element falls within the realm of the common general knowledge of the skilled person. In the author’s view, this is a more sensible standard for evaluating whether a claimed element is “well-understood, routine, or conventional.”
Should an examiner cite a single piece of prior art, such as a patent document or journal article, as evidence of an element being “well-understood, routine, or conventional”, the applicant may now challenge that assertion under the Berkheimer memorandum. It is then incumbent upon the examiner to rebut that point in an acceptable manner (step 4 of the memorandum). Such a rebuttal may take the form of evidence in accordance with steps 1-3 of the memorandum, or an affidavit wherein the examiner states, based upon his or her personal knowledge, that the additional element(s) represents well-understood, routine, conventional activity engaged in by those in the relevant art, in that the additional elements are widely prevalent or in common use in the relevant field, comparable to the types of activity or elements that are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a). It will be interesting to see whether examiners will be willing to provide such affidavits in due course (given that the sanctions for providing false testimony in a sworn statement can be severe in the US).
As a final point on the matter, according to the Berkheimer Training material issued for examiners (7 May 2018) it is necessary for the examiner to consider a combination of elements:
To support a rejection of a claim where the examiner takes the position that additional elements A and B are routine, the combination of A and B must be shown to represent well-understood, routine, conventional activity in the pertinent art
Thus, it may not be enough for an examiner to simply find each element and from that conclude that those elements are “well-understood, routine, or conventional.” Rather, it would seem that the examiner may have to find evidence that the claimed combination of elements was “well-understood, routine, or conventional.”
Is Berkheimer likely to change anything?
In short, most likely yes. Since issuance of the Berkheimer decision there have been a number of reversals of rejections under 35 USC §101.
For example, in Ex Parte David Galloway et al. (22 May 2018), which concerned a method of diagnosis, the Patent Trial and Appeal Board (PTAB) reversed a §101 rejection (“law of nature”) of the USPTO on the ground that the examiner had “not established with appropriate factual evidence that the claimed method uses conventional cell counting methods.”
Similarly, in Ex Parte Jadran Bandic, et al. (30 April 2018), which concerned a software invention, the PTAB reversed a §101 rejection (“abstract idea”) of the UPSTO for much the same reason as Ex Parte David Galloway et al. Specifically, the PTAB found that “The Examiner’s analysis of the second step of the Alice analysis is conclusory and unsupported”, and made it clear that unsupported statements from an examiner are insufficient for complying with Step 2B of the Alice/Mayo test.
It would appear that the Berkheimer decision might rein in the overly broad application of Step 2B of the Alice/Mayo test, thereby giving applicants for software and diagnostic inventions a fighting chance of making it past the patent eligibility test.