Posts Tagged: "patentability requirements"

3D printed human organs are coming increasingly close to being a reality according to several reports. In addition to potentially saving thousands of lives every year, this ground-breaking technology raises issues related to patent law that cannot be ignored. Are human organs and/or tissues that are created through 3D printing process that use naturally-occurring cells eligible for patenting? Or are such organs and tissues considered to be products of nature and therefore ineligible for patenting? The America Invents Act (AIA) creates serious questions, as do some recent Supreme Court ruling on patent eligibility.

A couple months ago I commented on Ex parte Khvorova, expressing disappointment in its analysis and concern over what this might mean since it is “the first PTAB decision in molecular biology since patenting in that field got turned upside down.” To follow up on these notions, and to give credit where credit is due, I wanted to briefly comment on Ex parte Boyden, which the PTAB issued September 2, 2015.

KAPPOS: “Back when I was an engineer we saw it in mainframe computers where you’d make an invention and frequently initially the software wasn’t fast enough to be able to run the algorithm. So the algorithm would first be built in silicon, really expensive, but you’d wind up then fabbing up chips to be special purpose chips to run the algorithm. And then later as the software got faster the underlying computer systems got faster you’d reimplement the same algorithm in software, same algorithm, same invention but just reimplement it in software and then even later after that when the ASIC density got good enough you’d reimplement yet again in an application-specific integrated circuit, an ASIC. And so you’d have a little bit of a hybrid, if you will, but more on the hardware side, it’s an IC. It’s again putting the algorithm in a chip. And so what you’d see by looking at that is that it made no sense to say that an algorithm was patentable if it was implemented in a hardware chip. But the same algorithm implemented in software was unpatentable. Just didn’t make sense to say that.”

KAPPOS: ”Companies like Microsoft and Apple and GE — all of whom are members [of the Partnership for American Innovation] along with IBM, Ford, DuPont and Pfizer as well as smaller companies like Many Worlds and Second Sight — all of them are engaged in the hard work of making major, I’ll call it bone-grinding innovations. Second Sight is literally coming up with electro mechanical and implantable human interfacing medical technology that enables blind people to see. And like you said, Gene, serious software development involving lots of super smart people and putting in tremendous amount of time with a lot of specialized expertise, devising solutions to very important problems. You know, enabling blind people to see — it’s hard to imagine a more tangible, practical and important problem than that.”

The United States Supreme Court is commonly known to resolve difficult issues of law. Yet, Alice v. CLS Bank[ii], last year’s unanimous Supreme Court decision, has caused confusion about whether computer-implemented business methods and software innovations are patentable under 35 U.S.C. §101. The question of patentability of software-related innovations – even those involving merely implementations of business-related innovations – seemed…

The panel decision in this case reads recent Supreme Court precedent to create an existential threat to patent protection for an array of meritorious inventions. It avowedly holds that “groundbreaking” new diagnostic methods that make a significant contribution to the medical field” are ineligible for a patent whenever they (1) incorporate the discovery of a natural phenomenon, and (2) the techniques involved in putting that discovery to its first practical use were individually known beforehand. In other words, the person who first discovers a natural phenomenon can never obtain a patent on any practical application of that new knowledge, however surprising or revolutionary the results, unless the steps she teaches to use it are independently novel. As the example of this case vividly shows, that cannot be correct.

While Mayo and Alice presented a two-part “framework” to address when a particular claimed invention preempts a “fundamental principle,” neither case purported to have that framework replace a preemption inquiry nor authorize a court to ignore the ultimate question, i.e., does the claim preempt a fundamental principle instead of merely claim a practical application of such a principle? The failure to consider preemption has resulted in courts and the PTO over-using §101 in a gatekeeper or threshold fashion for which it was never intended to be used, either as enacted by Congress or as interpreted by the Supreme Court.

This is a really important question both with respect to biologics and other interventions and also as the Federal Circuit does work with the Supreme Court’s body of precedents. We have basically two principle points. One is that in our view the Federal Circuit has to do a better job rationalizing and reconciling two different sets of precedent. One is the set of modern cases and the second is an older case that the modern cases embrace, Diamond vs. Diehr, which as we understand it adopts exactly the opposite rule from the Federal Circuit in this case, which is that the combination is what has to be new not the individual processes. And then second we believe that we have a case that fits squarely within what the Supreme Court intended to remain patent eligible after those more modern cases. So we filed an en banc petition and we thought that there would be amicus support for sure. But what we didn’t expect, to be honest, was the outpouring of interest and support that we received.

On some basic level everything can be characterized as an idea. It is also all too easy for those who are not technically trained to believe, no matter how wrongly, that implementation is a trivial or ministerial act. Just monitor the windmills, if they are operating at a less than optimal level adjust them, tilt the blades a little. No big deal. Anyone could have thought of that, and a college student could have written the code over a weekend. Moreover, windmills are extremely old technology, so merely applying a computer process to something so old can’t be patent eligible.

As the amici correctly argue, the panel’s decision striking down Sequenom’s noninvasive prenatal test strikes at the very heart of the patent system. Revolutionary diagnostic testing methods that cost tens of millions of dollars to produce should be the flagship of the modern patent system. But the panel’s misapplication of Mayo calls into doubt many meritorious inventions that benefit us all. Moreover, the panel’s reasoning simply cannot be squared with several innovations that the Supreme Court has historically upheld as proper statutory subject matter. Hopefully the entire Federal Circuit will agree to take up this important case so that vital innovations such as Sequenom’s patented method continue to be produced.

The key to obtaining a software patent is to thoroughly describe the system and processes from a technological level. As to Judge Chen explained in DDR Holdings, in order for software patent claims to be patent eligible they must not “merely recite the performance of some business practice known from the pre-Internet world along with the requirement to perform it on the Internet.” To be patent eligible claims to software must be “rooted in computer technology in order to overcome a problem specifically arising in the realm of computer networks.” Of course, this patent eligible example of software patent claims is extremely relevant for business methods because a naked business method is no longer patent eligible. To have a realistic chance of being patented business methods must be tied to a particular compute technology in a meaningful and substantial way. Said another way, the business method really needs to be performed by and through a concrete and tangible system, where the system and processes are painstakingly described.

The Federal Circuit affirmed. The asserted claims were not obvious because, although the claimed amounts (0.01% bimatoprost and 200 ppm BAK) fell within the range disclosed in the prior art (0.001-1% bimatoprost and 0-1000 ppm BAK), Allergan “had produced ample evidence of teaching away and unexpected results, and that such evidence fully support[ed] a conclusion of non-obviousness.” For example: (1) BAK is a toxin and “should be minimized in ophthalmic formulations to avoid safety problems,” (2) BAK decreases permeability of bimatoprost, and (3) BAK causes hyperemia at high concentrations. Thus, the prior art “’criticize[d], discredit[ed], or otherwise discourage[d]’ the use of 200 ppm BAK in a bimatoprost formulation.”

The first and most critical task in most eligibility analysis is carefully and precisely defining the subject matter of the claims as well as the natural phenomenon that is potentially being claimed. The superficial definitions in current court decisions are usually found in the part of a decision where the court explains what the patentee “essentially” or “generally” claimed. I understand that judges are not technology experts, but the current shortcut of boiling claims down to their “essence” is particularly problematic in a § 101 case. Everything is a “natural phenomenon” if this term is treated expansively.

Clearly, one does not get a patent on software or a computer program. Software, just like electronic circuits, or steam, or solar energy, or gears, or rubber bands — to name a few — is only a means to an end. Under the USPTO long time guidelines one receives a patent only if a) there is an invention b) if there is a proper Specification (an adequate disclosure to one skilled-in-the-art) and c) the so-called invention in the patent application is not abstract and not obvious.

Ex parte Khvorova is the first PTAB decision on patent eligibility in the life sciences. Until now, the PTAB has been remarkably silent on eligibility in life sciences in the midst of significant judicial activity. The invention relates to synthetically designed and produced small interfering RNA (“siRNA”) molecules, which were discovered in nature for their ability to suppress gene expression. Claim 85 recites a method of rationally designing siRNA molecules with optimal suppression efficacy.