Posts Tagged: "patentability requirements"

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.

The USPTO continues to issue patents related to biotechnology and organic chemistry inventions despite the Supreme Court rulings and USPTO guidelines implementing the ruling related to the scope of patentable subject matter. Although the sky has not fallen, applicants must expect more rejections under 35 U.S.C. § 101 and must budget for more office actions before receiving an allowance from TC 1600. Furthermore, applicants can expect these challenges in several art unit groups, particularly in art unit group 1630. As a matter of strategy, if a rapid allowance is sought, applicants should carefully draft applications and claims to comply with the Interim Guidelines and utilize options to speed prosecution. Because of the uncertainty in the relevant case law and its rapidly evolving nature, applicants should consider whether to appeal intractable rejections under § 101. Further analysis is necessary to determine whether appeals of rejections under § 101 by TC 1600 are successful.

During the last hearing of the House Judiciary Committee there was an attempt to insert language via amendment that would make it impossible for Kyle Bass and others to challenge pharmaceutical patents via post grant challenge at the Patent Office. Judiciary Chair Congressman Bob Goodlatte (R-VA) vociferously objected saying that if the amendment to prevent post grant challenges to pharmaceutical patents passed it would create a so-called scoring problem with the Congressional Budget Office (CBO). What an admission by Goodlatte! No legislative help is coming for pharma’s post grant challenge problem because the federal government likes the idea of some patents on important drugs being invalidated, which will save Medicare money.

Simply stated, any patent decision from the Supreme Court that cites stare decisis lacks all intellectual credibility given how arbitrarily and capriciously they have ignored their patent own precedent and the patent statutes over the past decade. Obviously, this Supreme Court doesn’t understand the true definition of stare decisis. Given how frequently the Court disturbs well-established principles and precedent in the patent space the use of stare decisis in this case is nothing more than a complete and total cop-out. It also insults the intelligence of anyone who has even casually observed the Supreme Court on patent matters over the past decade.

The idea that the Supreme Court is at all capable of understanding — let alone deciding — issues of a technical nature is ridiculous. Yet their individual and collective lack of knowledge hasn’t prevented them from reaching misguided decisions in a variety of cases. Like an Emperor without any clothes the Supreme Court seems blissfully ignorant of their own ignorance. Indeed, you would have to go out of your way to find nine less qualified people to decide issues of a technological nature.

Normally when there is a rejection the innovation itself has not been rejected, but rather the particular way in which it has been claimed is found to be unacceptable for one reason or another. The insidious nature of patent eligibility rejections, however, is that that innovation itself is rejected without regard to whether the innovation is useful, new, non-obvious and described well enough. A finality in the decision making process is reached even before any substantive inquiry is made about the nature and quality of the innovation. Such cursory decisions at the front end, without any factual inquiry into the merits of the invention, can render an entire category of innovation dead on conception, which is why patent eligibility has always been historically viewed as a low threshold inquiry, not the insurmountable mountain that it has become.

If U.S. patent eligibility rules were more clear and predictable, the useful art of software development would be more prevalent. The “notorious computer” of the European Patent Office offers a viable option for reaching this objective. This approach would make business less uncertain as to whether not their proposed investments in software could receive patent protection. And reducing this risk would promote the future useful art of software development.