The USPTO Guidance on Eligibility: a journey into the unknown

Former guest Kats are always welcome when they purr their way back into our lives. Last week it was Miri Frankel who treated us to a pleasantly unexpected comment on the Google-to-Alphabet branding story (here). This time round it's patent attorney Suleman Ali (Holly IP), who has been taking another look at life in the United States in the wake of that great nation's Guidance on Eligibility. This is what he has to say:
The United States Patent and Trademark Office (USPTO) Guidance on Eligibility: a journey into the unknown

The quest for the rules of eligibility
The USPTO Interim Guidance on Patent Subject Matter Eligibility which issued in December of last year (see Katpost here) is continuing to redefine the patentability landscape in the US. Few attorneys in Europe seem to recognise the extent of the changes that are happening. Fundamental questions about which inventions are constitute ‘eligible matter’ are being asked and answered by Federal Circuit decisions. At the moment we seem to be in the curious situation of not knowing what types of invention satisfy the US eligibility requirement in the fields of computer implemented inventions, business methods, chemistry, pharma and biotech. This has already had a major impact on US patent litigation, but there is a probably a more significant impact to come on the research and development ecosystem and the business models which companies involved in innovation will adopt.

Basic principles of eligibility: the judicial exceptions are now very broad

The jury was fascinated by the theory
of judicial exceptions
In the US inventions can only be granted for particular types of invention (here). Patents cannot be granted for inventions which ‘wholly embrace’ a judicial exception, i.e. laws of nature, physical phenomena and abstract ideas. It must be remembered that this ‘eligibility’ requirement is completely separate from novelty, obviousness, written description, etc. That means a ground-breaking significant finding is not necessarily an eligible invention. The Guidance defines the judicial exceptions very broadly, so that many inventions which would have previously been patentable no longer are. Naturally occurring products are in general no longer patentable, even when present in compositions with other molecules.  Natural correlations, such as those which are used as the basis of diagnostic inventions, are not patentable. Many business methods are now deemed to be ‘abstract ideas’. The Guidance sets out a two-part test for determining eligibility. The first part asks whether a judicial exception is involved, and the second part asks whether there is something ‘significantly more’ that would transform the claimed matter into an eligible invention. At this stage we know that the ‘significantly more’ requirement is not necessarily an easy one. It cannot be overcome by referring to conventional and routine techniques or steps. It is also clear that one cannot attempt to monopolise the underlying judicial exception by claiming at a ‘high level of generality’.

The updated Guidance: it is not getting easier

An updated Guidance was issued in July of this year (here). This does not really change things very much, and what seems clear is that ‘eligibility’ will continue to be a high hurdle. While Federal Circuit decisions continue to add to the list of inventions which are not eligible matter, we still don’t know what makes an invention to be eligible matter. That may be because parties are still pursuing claims which are too broad.  From the updated Guidance it is clear that ‘preemption’ is an important consideration when looking at eligibility. The patent claim must not ‘preempt’ other uses of the judicial exception. That means that other parties will not be hindered in developing technologies which also make use of the same judicial exception.

Ariosa Diagnostics v Sequenom

Ariosa Diagnostics, Inc. v Sequenom, Inc., No. 2014-1139 (Fed. Cir. Jun. 12, 2015) is a sobering example of how the US Courts will apply the eligibility requirement on biotech cases (see PatLit post here). The invention was based on the finding that foetal DNA (cffDNA) could be sampled from the blood of the pregnant mother, avoiding the need to use invasive techniques to obtain such DNA. The Court was of the opinion that the invention was meritorious but still found the claim to relate to ineligible matter. It said:
It is important to note that the ’540 patent does not merely claim uses or applications of cffDNA, it claims methods for detecting the natural phenomenon. Because generally one must be able to find a natural phenomenon to use it and apply it, claims covering the only commercially viable way of detecting that phenomenon do carry a substantial risk of pre-empting all practical uses of it.’

Clearly the problem here was the invention was simply claimed too broadly.

What does this mean for R&D?

Under the Guidance:
no more patents for trees
The Guidance prevents newly-discovered natural phenomena from being monopolised. Is that fair? One can imagine that it might have a positive impact on the way that R&D is carried out. It certainly means that a company may have to do more than discover the phenomenon to obtain a patent. That could promote innovation. Presumably there will be less  ‘dominant’ patents as a result and that will encourage incremental inventions in the same field.  Having less ‘dominant’ patents may also encourage collaboration between parties as negotiations could happen on a level playing field.
Thanks, Suleman, it's great to hear from you! This Kat suspects that we may hear from some of our many US-based patent-y readers too.
The USPTO Guidance on Eligibility: a journey into the unknown The USPTO Guidance on Eligibility: a journey into the unknown Reviewed by Jeremy on Monday, August 17, 2015 Rating: 5


  1. The US seems to be carrying out a big experiment in whether innovation benefits by making it harder to get patents. Congress does not seem to have expressed any disapproval of this. Once we are beyond the painful transition period it will be interesting to see whether there has been an overall benefit to the economy. Certainly there should be less patent wars if claims are going to be limited to those which are non-premptive.

  2. Re Anon at 13:33 - The effect on biotech and other life-sciences industries will very likely not become apparent until decades later. The "painful transition period" could prove to be very long and painful.

  3. As to mixtures of naturally occurring products-- the USPTO and the courts seem to have overlooked that the statue defines and invention as "an invention or a discovery", giving equal weight to the two classes of innovation. Will be interesting to see if this is discussed by the CAFC/SCOTUS anytime in the near future.

  4. I am puzzled as to why claiming the only commercially-viable way of solving a problem should be a bar to patentability. I can imagine why, as the EPO does, barring claims to all solutions to a particular problem would be deprecated. But if one player has the monopoly on the only commercially-viable way of solving a given problem, does not that encourage other players to research to make the other non-commercially-viable ways to solve the problem more commercially-viable, whether by technical, commercial or marketing steps? Many things which were once commercially unviable, such as powered flight, portable computing, video calling and the television, became so after further development effort. The first comercially-viable solution may not always be the best in terms of further development potential. Or do I miss something here?

    Another question, in a similar vein - if there are only two commercially-viable ways of solving a problem, and a company prepares and files applications to them both, then is there a problem? What if the two alternatives are presented in the same application, or as alternatives in the same claim?

    Bringing considations of commercial viability into questions of patent eligibility appears to create more problems than it solves.

  5. The Guidance is arguably a work in progress, and decisions like Ariosa are to say the least not helpful.

    Readers of patents4life will have learned by now that Sequenom has just filed a petition for en banc review.

    The two judges who authored the opinion of the court were both from an international trade law background and therefore did not have the insight into biotech cases that comes with experience in that field or in patent law generally. The claim was in my opinion over-broad and failed to set out explicitly key detail that turned the subject matter from an unpatentable natural principle to a patent-eligible application thereof.

    It is almost beyond comprehension how the court could have concluded that short DNA sequences amplified by PCR were natural phenomena: on the face of the opinion that finding is wrong by a mere 1000 to 1000000. Experienced practitioners could go on at great length about the misunderstanding of and misapplication of the Myriad opinion in a succession of recent Federal Circuit decisions.

    We can only hope that the case is re-heard en banc and that wiser counsels will prevail.

  6. Paul Cole,

    It will take more than just a wiser counsel as you note with the en banc comment.

    That en banc involves the body of Judges that have been brow beaten by the Supreme Court and will take the anti-patent lead so offered.

    It will take something more, something that does not exist today - a new body of judges combined with a jurisdiction-stripped Supreme Court not being able to reshape the nose of wax that U.S. patent law has become.

  7. In response to Anonymous at 8:50 and Paul Cole, the Ariosa v Sequenom decision probably does apply the present Guidance correctly and tries to interpret 'preemption' in this context. We'll need cases with narrower claims before we're going to find out what makes a claim eligible. However fingers crossed for the en banc review.

  8. Why are there no cat pictures on this blog post? I come here for cat pictures but there are not any. Please more cat pictures.

  9. Thanks Lashanda, and apologies for the omission. We must do better in future.

  10. Anonymous at 08:50:00 BST, one must appreciate that the Supreme Court is trying to prevent the monopolising of the building blocks of innovation. Essentially that is because of the perception across many technology areas that claims were granted which were simply too broad and these were hindering the activities of third parties too much. That is in principle a noble aim, even if not all agree. We in Europe would not attempt something so ambitious, and for that we need to take our hats off to what is happening in the US.

  11. Dear Lashanda, I apologise for the lack of cat pictures. I provided the pictures for this post and it was my intention for them to be amusing and yet helpful in understanding the issues being discussed. I have nothing against cats, but they are one mammal amongst many, and sadly under-represented in the classical paintings I like to use on my posts.

    Even if the pictures did not have cats in them, I hope you found them to be amusing or thought provoking.

  12. The anon-eh-mice appreciate a respite from cats...


  13. Anonymous @ 18:29,

    There are so many things wrong (legally) with the notion that what the U.S. Supreme Court is doing is "noble," I scarcely know where to begin.

    We could start with the U.S. Constitution which does not allocate that authority to the Court.

    That same Constitution creates Article III Courts of limited jurisdiction and prevents the Court from mere advisory opinions. Noting that the Court's own words of the mere potential harm are forward looking and conjectural (hint: "may"), one is required (if one is to think critically) to recognize that the Court is not applying or interpreting the law as written, but is legislating from the bench according to their own views of "what blocks."

    ALL patents block - that is what they do. That is what they are meant to do. It is the SOURCE of creativity to block and then spur new paths around that block. It is the utmost audacity (and ultimate hubris of the Court) for them to create an artificial limit and project from the future that no further innovation could flow from any one particular patent - no matter how broad that patent may be.

    This then is NOT "noble." This is abuse of power to suit one's philosophical views.

  14. Sequenom's petition for en banc review is now available at


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