New guidelines issued from the USPTO provide some positive insight as to how claims to diagnostic methods will be examined for patent eligibility.
In recent years the pursuit of diagnostic method patent claims in the U.S. has been a vexing and often futile quest for biotech patent practitioners and their clients alike. Following the Supreme Court’s landmark Mayo decision, the USPTO adopted a very tough stance toward diagnostic method claims, and has almost invariably rejected them, regardless of their form, as patent ineligible.
However, there may now be new hope for diagnostic method claims. The USPTO has just published a fourth set of subject matter eligibility examples, including two examples relating to diagnostic method claims (examples 29 and 31). These examples, particularly example 29, provide some useful insights/perspectives for drafting and amending diagnostic method claims, although there are some important caveats, as discussed below. What is striking is that the patent office appears to adopt a far more lenient view than previously of what claims are considered patent eligible. This article focuses on example 29, since it offers some surprising and significant outcomes for diagnostic method claims.
Example 29 provides a series of seven claims directed to diagnostic, “theranostic,” and treatment methods for “Julitis,” a condition relating to the hypothetical (but known) protein “JUL 1,” which the inventors have found to be present specifically in subjects suffering from Julitis. The claims are summarised below:
A two step “method for detecting JUL-1” which includes (1) obtaining a plasma sample, and (2) contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody.
A “method of diagnosing julitis” containing steps identical to (1) and (2) above, plus step (3), which recites “diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected.”
A “method of diagnosing julitis” that is identical to claim 2 but for the use of a porcine anti-JUL-1 antibody.
A “method of diagnosing julitis” that is identical to claim 3 but for the use of mAb-D33 monoclonal anti-JUL-1 antibody developed by the inventors.
A “method of diagnosing and treating julitis in a patient” reciting detection and diagnosis steps identical to those in claim 2, but further including administration of vitamin D, a previously unknown treatment step.
A “method of diagnosing and treating julitis in a patient” identical in form to claim 5, but reciting administration of anti-tumour necrosis factor (TNF) antibodies, a conventional treatment step for julitis, rather than vitamin D.
A “method of treating a patient with julitis” by administering to the patient an effective amount of anti-TNF antibodies.
As a reminder, the Patent Office has adopted a (conditional) three part “Mayo/Alice” test to determine claim eligibility as elaborated in its earlier guidance and examples, which is briefly summarized below:
All of the above claims easily pass through step 1 of the "Mayo/Alice" test, as they are clearly drawn to a process. Things get more interesting for the subsequent steps.
What general tips can be gleaned from the USPTO’s analysis of diagnostic method claims?
Where possible diagnostic claims should be drafted as method of detection claims without a diagnostic step, which would otherwise trigger the automatic conclusion that the claim is drawn to a judicial exception. This approach, of course, ignores whether such a claim, especially when reciting detection of a known protein, would actually be novel or non-obvious over the prior art. One possible strategy to overcome this potential prior art problem would be to include a step in which a sample is “collected from a patient identified as being at risk of [specific disease]”.
If a diagnostic step must be included in the claim, the claim should recite specific reagents, types of reagents, or detection methods that define an unconventional step. In their analysis of the above claims, the patent office certainly seems to have adopted a far more generous view than in the past of what it considers to be unconventional steps (e.g., the use of porcine antibodies or a specific monoclonal antibody).
If all else fails, the diagnostic or detection claim should also include a treatment step that recites the use of a specific treatment (or better yet, many types of specific treatments). Generally this is not desirable, as it presents a split infringement scenario that will likely render such claims difficult to enforce. However, some comfort might be found in the Federal Circuit’s recent Akamai decision, which held that in certain circumstances a method claim may be directly infringed even if steps are performed by different parties (e.g., a diagnostic step and a treatment step).
A major concern with the USPTO’s analysis of claim 1 (covering a “detection method”) is arguably in conflict with the Federal Circuit’s reasoning and decision in the recent Sequenom case relating to detection of cell free fetal DNA in material plasma. Indeed, several of the claims in Sequenom’s U.S. 6,258,340 patent were, like claim 1, two step detection method claims. In view of example 29, the USPTO would likely find many of Sequenom’s claims to be patent-eligible. Unfortunately, though, the court found Sequenom’s claims ineligible as purely directed to a natural phenomenon.. Importantly, given the profile of this case, Sequenom, together with a number of other interested parties have petitioned the Supreme Court to consider the case.
It should be noted that the new examples and analysis focus exclusively on patent-eligibility-not necessarily patentability of claims, an important distinction. More specifically, several of the claims analysed in example 29 appear to be unpatentable in view of the state of the art set out in example 29. For example, if JUL-1 was a “known” protein, it is hard to fathom how the detection method in claim 1 could be considered novel or non-obvious.
If nothing else, claim 7, drawn to a conventional, well known method of treating julitis, makes it crystal clear that the USPTO’s analysis is confined strictly to patent eligibility, apparently avoiding a more holistic approach that would give due consideration to the validity of diagnostic method claims under other sections of patent law. Notwithstanding these reservations, the latest guidance from the USPTO will be a most welcome and useful resource in countering patent eligibility rejections directed to diagnostic method claims.