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« Celltrion Healthcare Co. v. Kennedy Trust for Rhematology Research (S.D.N.Y. 2014); Hospira Inc. v. Janssen Biotech Inc. (S.D.N.Y. 2014) | Main | USPTO Issues Interim Guidance on Subject Matter Eligibility »

December 15, 2014

Comments

'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.

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.

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.

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?

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/

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.

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.

"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.

Well said Dan.

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

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