USPTO to Release Revised Subject Matter Eligibility Guidance

By Donald Zuhn --

In a conference call this morning, Drew Hirshfeld, U.S. Patent and Trademark Office Deputy Commissioner for Patent Examination Policy, announced that the USPTO would be releasing revised guidance on subject matter eligibility later today and that the guidance would be published in the Federal Register on Tuesday.  In fact, the revised guidance was made available for public inspection in the Federal Register reading room during the conference call (and can be found here).

The revised guidance will provide an integrated approach, applying to all types of subject matter, and take the Association for Molecular Pathology v. Myriad Genetics, Inc., Mayo Collaborative Services v. Prometheus Laboratories, Inc., Alice Corp. v. CLS Bank International, and other decisions into account.  In particular, the revised guidance will use the two-step analysis described by Justice Breyer in Mayo and discussed further in Alice (see "Thoughts on Alice Corp. v. CLS Int'l").

Mr. Hirshfeld noted that the Office's delay in releasing the guidance was due, at least in part, to incorporating more recent decisions such as Ultramercial Inc. v. Hulu LLC and even DDR Holdings, LLC v. Hotels.com, L.P. into the guidance.  In fact, he pointed out that the revised guidance was "pulled back" to incorporate DDR Holdings, which was issued by the Federal Circuit on December 5.

Noting that the Office has "taken to heart the feedback the public has given us," Mr. Hirshfeld indicated that the publication of the revised guidance would open a 90-day comment period, and he encouraged the public to submit comments on the guidance, adding that "we are still very interested in receiving people's feedback."  In addition, he announced that the Office would be holding a public forum on the revised guidance on January 21.  Mr. Hirshfeld added that the Office viewed the process of revising the guidance as an "iterative" one, and that the Office would "not hesitate" to make further changes as dictated by future court decisions and public feedback.  He said that Office was "trying to be as open and transparent" as possible with respect to the guidance.

With regard to the revised guidance itself, Mr. Hirshfeld declared that "most people will see that we made significant changes" as compared with the Office's prior subject matter guidance.  Most of these changes will come on the life sciences side, where Mr. Hirshfeld noted the "feedback was more critical."  In response to a question regarding changes to the guidance, Mr. Hirshfeld indicated that the revised guidance would incorporate all of the changes that the Office has been discussing publicly for the past several months (and which have been described in this space in a number of posts).  In particular, he noted that by applying to claims that recite or involve a judicial exception, the Office was using "too broad of a funnel."  In view of the Alice decision, the process outlined in the guidance would apply to claims that recite or are directed to a judicial exception rather than those that merely "involve" a judicial exception.  The revised guidance will also differ with respect to application of the "markedly different" standard.  Mr. Hirshfeld acknowledged that while the previous guidance was "heavily weighted on structure," the revised guidance has been broadened to include other markedly different characteristics such as functionality.  Examiners will also be asked to apply a markedly different analysis in the first step of the test, which Mr. Hirshfeld expected would "help examiners make an early determination" as to subject matter eligibility, and thereby "simplify" the process.  In an effort to further simplify the process, the Office has removed the 12-factor test that was set forth in the Myriad/Mayo guidance from the revised guidance, which Mr. Hirshfeld said was "too confusing."  As the Office has been suggesting for months, however, the revised guidance, like the Myriad/Mayo guidance released in March, will not be confined to DNA.

Among the changes will be several new examples in the Myriad/Mayo space.  These examples will be made available on the Office's subject matter eligibility website, which will be going live later today.  Mr. Hirshfeld noted that some of the new examples will be similar to those presented by June Cohan, a Legal Advisor with the USPTO's Office of Patent Legal Administration, at the BIO International Convention in San Diego in June (see "Docs @ BIO: USPTO Provides Update on Myriad-Mayo Guidance").  Mr. Hirshfeld noted that examples in the Alice space are expected to be added to the website in one or two weeks, with the delay on the hi-tech side being due to the recent Ultramercial and DDR Holdings decisions.  He also stated that "carefully crafted hypotheticals" were required in the Alice space because "we feel we need to give more guidance than examiners are getting from the cases."

Patent Docs will provide a more detailed analysis of the revised guidance in a subsequent post.

Comments

[The Big Lebowski]

'He said that Office was "trying to be as open and transparent" as possible with respect to the guidance.'

The office waited nine months after Myriad to issue its first set of guidelines, which were issued without public input. If you believe the office is really trying to be open and transparent, then I have some land in Florida to sell you.

[Not the Aussie SC]

It is quite amusing watching the PTO try to fit Myriad decision in its criteria.

Apparently nobody told them that isolated DNA with the same sequence as genomic DNA found in nature can have many more functions than just coding for a protein.

[David Mencher]

The revised Guidance is fatally flawed, in maintaining the definition of a claim "directed to" a naturally occurring product or natural law as any claim "reciting" a naturally occurring product or natural law.

[[email protected]]

David: "The revised Guidance is fatally flawed, in maintaining the definition of a claim "directed to" a naturally occurring product or natural law as any claim "reciting" a naturally occurring product or natural law."

As an initial matter, if a claim recites a naturally occurring product or a "natural law" (whatever that is supposed to mean), there's a much better chance that there is a subject matter eligibility problem.

Can you explain your objection in more detail, David?

[Greg DeLassus]

I am sort of lukewarm about the Guidance itself. As Courtenay Brinckerhoff notes (URL below), it is an improvement that they are willing to consider functional limitations. On the other hand, I am really lost as to how the three step analysis is supposed to apply to diagnostic methods. What does it mean to be "markedly different" than a law of nature? Or are diagnostic methods always supposed to go to Step 2B?

While the Guidance itself is only so-so, I find the new examples to be great. Really a 500% improvement over the last set. Gone is the nonsense about gunpowder and pomelo juice.

I agree with "not the Aussie SC" about the logical inconsistency between Myriad and the new Guidance flowchart. To be fair to the PTO, however, this is the SCotUS' fault, not the PTO's. Isolated genomic DNA has new functionalities not found in DNA-in-the-chromosome (the ability to work as a probe, for example). The SCotUS did not understand this, and therefore we are now stuck with a bum opinion. The PTO can hardly over-rule the SCotUS, so they simply have to live with the logical inconsistency (as do we all).

http://www.pharmapatentsblog.com/2014/12/15/uspto-finally-issues-new-guidance-on-patent-subject-matter-eligibilty/

[Paul Cole]

The USPTO is to be congratulated on getting its "Christmas Message" out on time.

It is a very lengthy document and detailed study will be required to reveal its true significance.

However there is also a set of nature-based product examples which has appeared at

http://www.uspto.gov/patents/law/exam/mdc_examples_nature-based_products.pdf

Connoisseurs of gunpowder will be relieved to learn that it is no longer considered to be a natural product.

Amazonic acid continues to appear as an example. Rejection of a claim to purified amazonic acid is based on the premise that the purified acid is structurally and functionally identical to amazonic acid in the leaves. Previously we were told that many kilograms of the leaves had to be eaten to achieve the postulated anti-cancer effect, whereas only a small amount of the purified material achieved that effect. Instead of changing the outcome to reflect real life and established case law the new example preserves the outcome at the cost of deviating from practical reality known to any pharmaceutical chemist. Some progress, but more work needed, as a tactful teacher might say.

The example on purified proteins appears based on pure science-fiction. Apparently the bacterium Streptomyces arizoneus stores antibiotic L in the form of hexagonal-pyrimidal crystals. Is anyone aware of any such phenomenon? A Google search has revealed magnetotactic bacteria that orient along the magnetic field lines of Earth's magnetic field. To perform this task, these bacteria have organelles called magnetosomes that contain magnetic crystals. That was the only example found by Google and in particular there was no report of crystalline penicillin or other antibiotic within cells. Even as a teaching example, such counter-factual propositions appear unwise.

The example based on Funk Brothers v Kalo is slightly toned down but does not really provide a satisfactory explanation of the opinion of William O Douglas, unsurprisingly since the opinion is so difficult to understand. The inoculant, being a mixture of two species of bacteria mixed by the hand of man, is indisputably a composition of matter, but the novelty is in the broad principle, unaffected by any identifiable other property in the bacteria. Patentability acknowledged for a mixture of two particular identified bacterial species represents a positive step forward.

The nucleic acid example provides an illustration of an ineligible isolated sequence, but unfortunately there is no corresponding nucleic acid sequence example that is eligible, despite candidates being given in the submissions. Sequences with substitution modification are not naturally occurring and their eligibility gives no indication of the boundary between naturally occurring sequences that are eligible and those that are not.

There are similar examples directed to antibodies, microorganisms and cells.

Overall, the Office is "stumbling in the right direction" but could benefit from more input from the public.

[Dan Feigelson]

Greg DeLassus: I think we all agree that "The PTO can hardly over-rule the SCotUS,". But instead of "liv(ing) with the logical inconsistency" of those decisions, the PTO can choose to apply rulings that are devoid of logic or rationality in as narrow a fashion as possible, precisely because of that inconsistency. If scotus thinks the PTO gets it wrong - i.e. that the PTO applies the decision too narrowly - scotus has shown itself to be far from shy about expressing its displeasure. Instead we continue to get gobbledygook from the PTO that, as Paul Cole says, is a step in the right direction, but still far more than was necessary for the PTO to give the appearance of attempting to comply with the myriad/mayo/alice group of incomprehensible decisions. The PTO's willingness to be a partner in scotus' myopia will come at the expense of investment in potential medical advancements.

[[email protected]]

"Isolated genomic DNA has new functionalities not found in DNA-in-the-chromosome (the ability to work as a probe,"

Hybridization to its complementary sequence is not a "new functionality". It's what DNA does. What you see as "new" is the abstract meaning that human beings lay on top of particular hybridization events.

Pretty sure the Supreme Court recognized that expressly in the Myriad decision.

[Not the Aussie SC]

Well said Dan.

Kaptkor, good luck trying to get a pcr to work if your primers are chromosomes.