By Kevin E. Noonan --
A few years ago, former PTO Solicitor General Nancy Linck arose from the audience at the BIO International Conference to provide her thoughts on how the Office had responded to the Supreme Court's decisions in Mayo v. Prometheus Labs and Association of Molecular Pathologists v. Myriad Genetics (see "USPTO Provides Update on Myriad-Mayo Guidance"). General Linck voiced her disappointment at the manner in which the Office had attempted to craft rules consistent with those decisions; in her view, the Office's responsibility was to provide the Court (and the patent community) with the benefit of their expertise and craft rules consistent with the Constitutional mandate that the patent system promote progress (even if the Supreme Court left open the possibility that this would not be the case). General Linck spoke forcefully and clearly from her heart, and she received (and deserved) a standing ovation that day.
On the podium and uncomfortably the recipient of General Linck's point of view was Drew Hirschfeld, at the time the head of the Office's legal department. Today he is Commissioner for Patents, and in the years since that day the Office's pronouncements on how the law of patent-eligible subject matter should be applied have been both more favorable to patent applicants and more consistent with patents promoting innovation than were those first set of guidances. Like Plato emerging from his famous cave, the Office opened the doors and drew back the shades of whatever closed room its officials inhabited in the first dark days of these Supreme Court precedents, and has since begun to craft guidances that permit (albeit still in only an attenuated fashion) applicants to receive patents more commensurate with their contributions to the Useful Arts.
The latest guidance, distributed to the Examination Corps on May 4th and to the rest of us on May 5th is an example of this changed mindset (see memorandum entitled "Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant's Response to a Subject Matter Eligibility Rejection"). This new guidance has been discussed here (see "USPTO Issues Update to Subject Matter Eligibility Guidance") and elsewhere. While others properly ponder the minutiae and nuances of this guidance, it may be worthwhile to try to draw some more generalized lessons from them. The first bit of good news is that the guidance is focused on the claims (where of course it should be). Fortunately the Office seems content to abandon any attempt to accommodate outmoded concepts of "inventiveness" or "inventive concept" that are divorced from the statute, or to search for the "gist" or "heart" of the invention. Rather, Examiners are instructed that they must identify the abstract idea, the law of nature/natural phenomenon, or product of nature in first prong of Mayo/Alice test in the claim language itself. Moreover, the Memorandum draws a distinction between claim limitations that "set forth" a judicial exception (which are thus self-evident) and those that merely describe an exception (where the Examiner must "explain subject matter those limitations describe, and why the described subject matter is a judicial exception"). This portion of the memorandum also requires the Examiner set out a reasoned rationale for the arguments regarding the presence of an abstract idea, the law of nature/natural phenomenon, or product of nature in the claim and whether such claim elements recite or are directed to a judicial exception.
Turning to the second prong, whether the claim recites "significantly more" than the abstract idea, the law of nature/natural phenomenon, or product of nature, Examiners must identify the additional elements of the claim (again, expressly and clearly) and explain why these elements taken individually and in combination do not amount to a claim as a whole that is significantly more than the judicial exception. This portion of the Memorandum emphasizes both considering the additional elements in combination and considering the claim as a whole. (However, and perhaps inevitably, the analyses set forth in the Examples 28-31, "atomize" these elements and their relationship to the abstract idea, the law of nature/natural phenomenon, or product of nature, before joining them, sometimes in several combinations, to probe whether the combination supports a conclusion of eligibility where the individual elements themselves do not.) In performing this assessment, the Memorandum instructs Examiners to identify either instances where courts have recognized elements or combination of elements to be "well-understood, routine or conventional," or the skilled worker would so recognize the elements, again considered individually or in combination. The Memorandum in this regard contains one important "caution," wherein:
[M]ere knowledge of the particular laboratory technique or use of the particular laboratory technique by a few scientists is not sufficient to make the use of the particular laboratory technique routine or conventional in the relevant field.
The Memorandum has, it seems, also been influenced by the Office's current patent quality initiative, emphasizing that rejections grounded in Section 101 must set out the rejections' rationale with "clarity."
The Examples (which will be separately discussed in this space), contain their own caution: that they are intended to be illustrative only, and that Examiners (and presumably applicants and the public) should not rely upon them in asserting (or rebutting) rejections under Section 101. (This admonition seems a bit unrealistic, particularly from the applicants' side, because it will certainly prove hard to cite these examples should a claim be "on all fours" with one of them. Although alternatively this may be nothing more than a caveat that just because a claim resembles an example applicants should not be surprised if the Office decides that a particular claim is nevertheless patent ineligible.)
Taking the examples as a whole and considering both the express claim language and the Office's analysis of eligibility vel non of each of them, some trends and (current) PTO conclusions regarding eligibility are clear. For products that can be considered "products of nature," those comprising alterations in the compounds not found in nature (e.g., mutations, chemical reactions, changes in structure or physical form) are eligible. This is not a change in Office policies; earlier examples have made this eligibility determination. In these Examples changes other than structural ones are also considered patent eligible by the Office; these include formulations (particularly with components not found together in nature) that change properties or functional characteristics of product of nature, as well as changes in physical form (such as crystal structure) provided that these changes are related to changes in functional properties (in Example 30, for example, naturally occurring crystals of a natural sweetener are rendered eligible by converting them to more homogeneous in size and having better dissolution properties. The Office also exemplifies unconventionality of other aspects of the claimed invention (such as using microneedles for vaccination with otherwise patent-ineligible peptides; Example 28) to support eligibility.
For method claims, and particularly methods related to arriving at a diagnosis of disease (Example 29), illustrate an anomaly (albeit at the same time providing some comfort for claiming such methods going forward): detection methods per se (that do not recite a correlation that can be characterized as a law of nature) are eligible, if only because by not reciting anything that could be considered a law of nature the analysis is not implicated. Even for methods that do recite a correlation that could be considered a law of nature the Office interprets those that also recite novel reagents (porcine antibodies or monoclonal antibodies) or methods (hybridization detection methods such as SNOM or new amplification methods, such as "Cool Melt" PCR (all of which are hypothetical)) to be eligible. Method of treatment claims (which have not been held by courts to be patent ineligible (but see Bristol-Myers Squibb v. Merck) are considered eligible by the Office in these Examples when they comprise novel treatment methods of administration to patients diagnosed using the method, or specific treatment methods of administration to patients diagnosed using the method. Indeed, one lesson gleaned from the Examples is that claims reciting elements at a high level of generality are more likely to be considered ineligible (despite the Federal Circuit's treatment of Myriad's claims in Myriad Genetics v. Ambry).
Turning to what is not patent eligible according to these Examples, products of nature per se remain (as they always have been) ineligible (the Office making ineligibility more explicit that even when claimed at certain percentages or in combination with other naturally occurring excipients such as water that do not change any of the product's properties). For diagnostic methods, Mayo and AMP v. Myriad (Federal Circuit) compels the conclusion that such claims broadly reciting the correlation between a marker and a disease are ineligible (indeed, Example 31 provides modifications of the BRCA gene claims in eligible and ineligible embodiments). The Office's rationale is also based on the use of "mental steps" in making the correlation, a conclusion that is not mandated by the case law. Nevertheless Example 29 sets forth this rationale in its analysis of claim 2:
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the law of nature, the claim recites additional steps of obtaining a plasma sample from a human patient (step a), and detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting resultant binding between JUL-1 and the antibody (step b). Obtaining a sample in order to perform tests is well-understood, routine and conventional activity for those in the field of diagnostics. Further, the step is recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., a mere data gathering step necessary to use the correlation. Detecting 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. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional machine or a transformation of a particular article, in this step that distinguishes it from well-understood, routine, and conventional data gathering activity engaged in by scientists prior to applicant's invention, and at the time the application was filed, e.g., the routine and conventional techniques of detecting a protein using an antibody to that protein. Further, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and detecting steps does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
This assessment also extends the ineligibility concept for these claims to more expressly base it on the "information" content (consistent with Judge Dyk's analysis in Genetic Technologies v. Merial).
While on balance this Guidance and the Examples illustrating the Guidance are an improvement on earlier iterations, the analysis continues to be frustrated by resistance to fully embracing consideration of the claims as a whole. It is unclear why this analysis should not arrive at patent eligibility for using a conventional method with a novel biomarker to produce a novel result (even if it is based on an underlying law of nature). Mayo is not to the contrary: recall that every step in the recited method had been performed in the prior art, so that the only inventive aspect was in the correlation. By definition, using a conventional method with a novel biomarker to produce a novel result is not the same, and certainly "promotes progress" pursuant to the Constitutional mandate. Also absent (but here representing a sin of omission) is an express recognition that differences in purity with functional effects (the difference between chewing a pound of yew bark and taking a pill, for example), or producing a product having a specific activity different from what is found in nature, should be patent eligible. Even in the vaccine example (#28) the Office did not include instances of, inter alia, immunological assays like sandwich assays to distinguish what occurs in nature and what is invented by man. The Office also seems to have conflated (or, more kindly, synthesized) the "routine, well-understood and conventional" standard from Mayo into the Myriad product of nature analysis; while it may be likely that the Supreme Court will one day perform that synthesis, prudence suggests that we let the Court do it any not have the Office try to help.
It should also be recognized that the Office expressly did not consider in drafting the Guidance or the Examples recent case law (including Sequenom and Merial) and that at least one of the claims (Claim 1 of Example 28) that the Office considers patent eligible would not be considered patent eligible under the Federal Circuit's Sequenom decision. In view of the fact that Sequenom filed a petition for certiorari that the Supreme Court has not granted or denied the eligibility of such claims must be at best considered provisional.
At a high level of generality, it can be understood that what the Office is unwilling to acknowledge (and perhaps doesn't think it can, another instance of hands being tied by inelegant expressions of the law by the Supreme Court case law) is the distinctions attendant on qualitative and quantitative differences between what is in nature (and thus perhaps should be "avallable to all men"): when differences in use (taxol) or novel properties related to concentration, specific activity, etc. evince "the hand of man" then eligibility should be acknowledged. This Guidance and the Examples suggest that we may be getting there, but not yet.