The past couple of weeks have brought some slightly brighter news for innovators in life sciences and software fields seeking patent protection in the United States. First, the US Patent and Trademark Office (USPTO) issued an update to its Interim Guidance on Subject Matter Eligibility which provides some much needed clarification on what is expected from examiners, as well as additional examples which will give new hope to applicants with inventions relating to diagnostic methods. Second, the US Court of Appeals for the Federal Circuit (CAFC) issued a rare decision (Enfish LLC v Microsoft Corporation, appeal no. 15-1244 [PDF, 604kB]) finding that a computer-implemented invention is not ‘abstract’, and is therefore patent-eligible.The USPTO’s updated guidelines require examiners to provide more detail in their rejections, to provide distinct rejections for every claim, and to provide more reasoning when maintaining rejections in the fact of applicant arguments. They also prohibit examiners from expanding the scope of unpatentable subject matter beyond the specific examples provided by court rulings. These clarifications will hopefully create greater certainty and consistency in the approach taken by examiners across all fields in which subject matter eligibility is commonly at issue.
The new life sciences eligibility examples will also be welcomed, especially by applicants with inventions in the field of diagnostics. At the same time, however, at least one of those examples also serves to highlight just how absurd the approach to subject matter eligibility has become in this area, thanks in large part to the US Supreme Court tying itself in knots trying to establish a consistent approach, while at the same time avoiding setting down any hard and fast rules about identifying excluded subject matter within the established categories of ‘abstract ideas’, ‘laws of nature’ and ‘mental steps’.
Interestingly, the USPTO’s ‘diagnostic’ example, and the patent-eligible computer-implemented invention in Enfish have something in common – both demonstrate that the most effective way to avoid a finding of ineligibility is to bypass the eligibility analysis altogether, by ensuring that the patent claims are not ‘directed to’ (i.e. ‘recite or describe’) any recognised judicial exception, such as a law of nature or abstract idea.
The Two-Step Eligibility Test
In order to understand both the CAFC and the USPTO approaches to subject matter eligibility, it is necessary to understand the approach established by the US Supreme Court through the Mayo, Myriad and Alice cases. This approach can be distilled down to two steps:- determine whether the claims at issue are ‘directed to’ a patent-ineligible concept (the USPTO guidance calls this ‘step 2A’, because its ‘step 1’ is the conventional check that the claim, on its face, defines something that falls within one of the four statutory categories of process, machine, manufacture, or composition of matter); and
- if this threshold test is met (i.e. the claims are directed to a patent-ineligible concept), consider whether there are elements of the claim which, individually and/or ‘as an ordered combination’ provide something more that is sufficient to ‘transform the nature of the claim’ into a patent-eligible application of the ineligible concept (which the USPTO guidance calls ‘step 2B’).
The notion of a claim being ‘directed to’ a patent-ineligible concept is clearly tricky. For the inquiry to be meaningful, it is apparent that there must be claims that are not ‘directed to’ such concepts and, indeed, there are entire fields of mechanical, electrical, and other categories of well-established subject matter for which this is plainly not an issue at all. At the same time, for the second step of the analysis to serve any purpose, it must be the case that a claim can be ‘directed to’ an ineligible concept, and yet ultimately be found to comprise something significantly more than that concept, such that, in total, it defines patent-eligible subject matter.
The USPTO guidance treats ‘directed to’ as meaning ‘sets forth or describes’, and not merely as ‘involving’ a judicial exception such as an abstract idea or law of nature. For the analysis to move to the second step (i.e. the USPTO’s ‘step 2B’) it must therefore be possible to point to something that is actually recited in the claim which constitutes the exception.
Hypothetical Absurdity in the USPTO Guidance
One of the USPTO’s new examples relates to the hypothetical discovery of a specific protein, ‘JUL-1’, found to be present in the blood plasma of people with an immune system disorder called ‘julitis’. The example discusses seven claims, of which all but one are considered patent-eligible. Here, I am only going to look at two of the exemplary claims.The first hypothetical claim is as follows:
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.
The guidance explains that this claim is patent-eligible because the steps (a) and (b) ‘do not recite or describe any recognized exception’. This conclusion is based on an analogy with the Supreme Court’s analysis in Mayo Collaborative Services v. Prometheus Laboratories, Inc., in which the Court stated that claimed steps of administering a drug to a patient and determining the resultant level of 6-thioguanine ‘are not themselves natural laws’. Since the claim is therefore not ‘directed to’ a judicial exception, there is no need to move on to the second step.
The second hypothetical claim is directed to the use of the steps recited in the first claim as part of a diagnostic method:
2. A method of diagnosing julitis in a patient, said method comprising:
a. obtaining a plasma sample from a human patient;
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; and
c. diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected.
Unlike claim 1, this claim is ‘directed to’ a judicial exception, because the diagnostic step (c) describes the ‘natural law’ that people with julitis have the JUL-1 protein in their blood plasma. As a result, this claim requires consideration under the second step of the Supreme Court’s test, i.e. the USPTO’s ‘step 2B’.
Surprisingly (to me, at least) the claim fails this step of the test, and is found to be patent-ineligible, even though the same two steps (a) and (b) were patent-eligible in the hypothetical claim 1. The guidance explains that ‘[o]btaining a sample in order to perform tests is well-understood, routine and conventional activity for those in the field of diagnostics,’ and that ‘[d]etecting whether JUL-1 is present in the plasma sample merely instructs a scientist to use any detection technique with any generic anti-JUL-1 antibody.’ Furthermore, ‘[w]hen recited at this high level of generality, there is no meaningful limitation … in this step that distinguishes it from well-understood, routine, and conventional data gathering activity’. Nor is the claim saved by consideration of the additional elements as a combination because those elements do not ‘act in concert to improve a technical field’ and the claim ‘does not invoke any of the considerations that courts have identified as providing significantly more than an exception.’
Personally, I think this is absurd. How can adding a limitation to a patent-eligible claim result in it becoming ineligible? According to the USPTO’s reasoning, the following claim – which is identical with hypothetical claim 1, but for the addition of a limitation which describes an act within the ‘mental steps’ exception – is also wholly ineligible for patent protection:
1. A method of detecting JUL-1 in a patient, said method comprising:
a. obtaining a plasma sample from a human patient;
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; and
c. reading a novel while waiting for a result of the detecting step.
If this is right, then surely it indicates that there is something seriously amiss with either the Supreme Court’s test, or the USPTO’s application of the test?
Patent Eligible Software at the CAFC
Meanwhile, at the CAFC, a computer-implemented invention has been found patent-eligible on the basis that the claims at issue are not ‘directed to’ a judicial exception (in this case, the relevant exception would be ‘abstract ideas’), and therefore are not subject to analysis under the second step of the Supreme Court’s test.The patents in the Enfish case claim methods and systems for manipulating a particular novel form of database structure. By way of example, claim 17 of US Patent No. 6,151,604 recites:
A data storage and retrieval system for a computer memory, comprising:
means for configuring said memory according to a logical table, said logical table including:
means for indexing data stored in said table.
- a plurality of logical rows, each said logical row including an object identification number (OID) to identify each said logical row, each said logical row corresponding to a record of information;
- a plurality of logical columns intersecting said plurality of logical rows to define a plurality of logical cells, each said logical column including an OID to identify each said logical column; and
If this claim were to be examined at the USPTO today, I dare say there would be a good chance that an examiner would argue that it is directed to the abstract idea of using a ‘self-referential’ table structure for storing information in a database. If so, then the eligibility analysis would proceed to the next step (i.e. ‘step 2B’), in which the examiner would have to determine whether there are elements in the claim that add something sufficient to transform the nature of the claim into a patent-eligible application of the abstract idea. It is hard to see how this could be the case, considering that everything in the claim, beyond the logical structure of the table itself, is defined wholly in terms of broad, generic and conventional computer functionality (e.g. ‘means for configuring a memory’ and ‘means for indexing data’, although it is necessary to keep in mind that so-called ‘means plus function’ elements are construed under US law as limited to the structures/algorithms disclosed in the specification, and equivalents).
Fortunately for Enfish, the CAFC saw the claim differently:
… Indeed, some improvements in computer-related technology when appropriately claimed are undoubtedly not abstract, such as a chip architecture, an LED display, and the like. Nor do we think that claims directed to software, as opposed to hardware, are inherently abstract …. Software can make non-abstract improvements to computer technology just as hardware improvements can, and sometimes the improvements can be accomplished through either route. We thus see no reason to conclude that all claims directed to improvements in computer-related technology, including those directed to software, are abstract and necessarily analyzed at the second step of Alice, nor do we believe that Alice so directs. Therefore, we find it relevant to ask whether the claims are directed to an improvement to computer functionality versus being directed to an abstract idea, even at the first step of the Alice analysis.
In this case, the CAFC agreed with Enfish that its novel data tables provided a number of advantages over conventional (‘relational’) database structures, and thus the focus of the claim was on ‘an improvement to computer functionality itself, not on economic or other tasks for which a computer is used in its ordinary capacity.’
The CAFC therefore concluded that the Enfish claims were not abstract according to the first step of the Alice test, and that it was not necessary to proceed to the second step.
Conclusion – Small Steps in the Right Direction?
Recent experience in the US courts, and at the USPTO, suggests that claims which fall foul of the first step of the Supreme Court’s patent eligibility analysis are rarely saved at the second step. The latest update to the USPTO guidance, and the decision of the CAFC in Enfish, demonstrate that the best hope for a claim is to avoid being ‘directed to’ a recognised judicial exception in the first place.For diagnostic tests this may mean claiming the steps in the test – even if they are generally conventional, and distinguished only by what is being tested for – without claiming any actual step of diagnosis. For computer-implemented inventions, one strategy may be to focus on the data structures used, and on associated improvements in the way in which the information they contain is processed.
Of course, subject matter eligibility is only the first hurdle. The claimed invention must also satisfy the requirements of novelty and inventive step. If applicants are forced to omit limitations from a claim in order to satisfy eligibility requirements (as in the USPTO’s ‘julitis’ hypothetical) what remains may not include anything that is new and nonobvious.
Much of this still seems fairly unsatisfactory to me and I suspect that, despite some small steps in the right direction, we can expect uncertainty and inconsistency – not to mention further updates to the persistently ‘interim’ USPTO guidance – to continue for the foreseeable future.
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