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Patentable Subject Matter Under 35 U.S.C. § 101: Part 2 – Application in the Software and Life Science Fields

This post is the fourth in a series written by Nashville attorney Shane Cortesi on patent protection.

As I mentioned in my previous post on patentable subject matter under 35 U.S.C. § 101, the law in this area has been in a state of flux over the last few years, especially in the case of process patents.  This week, I’ll discuss recent § 101 cases in the software and life science fields.  The common theme in both fields is that enlisting the help of a creative patent attorney may increase a patent applicant’s chance of meeting the patentable subject matter requirement.

Patentable Subject Matter for Software Inventions

Because the heart of software-related inventions often involve only the tangential use of a machine, software-related inventions often present difficult patentable subject matter questions.  Fortunately,  recent Federal Circuit cases involving the patentability of software-related patents provide a helpful road-map to patentability of these inventions.

For example, in Cybersource Corp. v. Retail Decisions, Inc., the first claim of the patent was directed to a method of detecting credit card fraud between a consumer and a merchant over the internet.  In particular, the method relied on comparing the internet address information used for a particular purchase to internet address information used in previous transactions with the same credit card to see if the internet address information in the present and past transactions was consistent.  The second claim was directed to a computer readable medium (e.g., a disk or other data storage device) containing program instructions for a computer to perform the method.  The Federal Circuit invalidated the first claim, reasoning that the claim was directed to an abstract idea and that even if the internet could be viewed as a machine, it was clear that the internet itself could not perform the claimed method.  The patent eligibility of the second claim at issue, in my opinion, was a closer question.  The court first held that this claim was in reality, a process claim, instead of a machine claim, because the invention underlying the claim was a method for detecting credit card fraud – not a manufacture for storing computer readable information.  The court then found the claim failed to meet either prong of the machine-or-transformation test because the claim merely required the manipulation or reorganization of data (as opposed to transformation of data) and the incidental use of the computer did not impose a meaningful limit on the claim’s scope.  Thus, the court held that the second claim was also directed to non-statutory subject matter.

From a patent attorney’s perspective, perhaps the most important part of the Cybersource decision is the manner in which it distinguished an earlier case that found a software-related invention patentable subject matter.  In particular, in Cybersource, the court distinguished the instant invention from the patented invention in its prior Research Corp. Techs., Inc. v. Microsoft Corp. decision, which involved a method of creating digital images.  According to the court, the distinction was that unlike the invention in the instant case, the method found to constitute patentable subject matter in Research Corp could not, as a practical matter, be performed entirely in the human mind.  Consistent with this distinction, the Federal Circuit in the recent Ultramercial, LLC v. Hulu, Inc. decision upheld the patentability of an 11-step process of distributing copyrighted contents over the internet.  Significantly, the process could not be performed in one’s head but rather required intricate and complex computer programming and required the use of an internet website.  Thus, the claim drafting tip from these recent decision seems to be the following:  ensure that the claimed method cannot be performed entirely in the human mind and, to the extent possible, require the use of intricate and complex programming and the use of a machine.  Of course, care should be taken so that the required use of additional programming steps and/or the required use of a machine do not allow competitors an easy opportunity to design around one’s invention.

Patentable Subject Matter for Life Science Inventions

In my view, the following invention have been subject to the most amount of debate when it comes to patentable subject matter in the life sciences:  1) man-made organisms; 2) naturally occurring materials (e.g., DNA); and 3) the use of diagnostic methods.  Ever since the Supreme Court’s 1980 decision in Diamond v. Chakrabarty, which held that a man-made organism was patent-eligible, courts generally have held that man-made organisms and natural compounds in isolated form are patentable subject matter.  (An exception is that, due to the enactment of recent legislation, human organisms are not patentable subject matter unless they were claimed in a patent issued before September 16, 2011).  Consistent with this precedent, in July of this year, the Federal Circuit held that isolated DNA molecules constitute patentable subject matter in the case Ass’n for Molecular Pathology v. U.S. Patent and Trademark Office.

In my view, the more difficult patent eligibility questions in the life sciences arena seem to involve diagnostic methods.  For example, in Classen Immunotherapies, Inc. v. Biogen Idec, the three patents at issue were related to a method of reducing the risk of chronic immune-mediated disorders by choosing a particular immunization schedule.  According to the patentee, two of the three patents were infringed when a health care provider reads the relevant literature and selects and uses an immunization schedule that is of lower risk for the development of a chronic immune-mediated disorder.  Meanwhile, the patentee argued that the third patent was infringed when a person merely reviews relevant published literature, regardless of whether that person selects and uses an immunization schedule.  Reviewing the patentability of the three patents under § 101, the Federal Circuit held that the first two patents involved the physical step of immunization and thus were patent eligible.  Meanwhile, according to the court, the third patent was merely an unpatentable mental process.

Upon a careful review, Classen suggests that patentability under § 101 may often depend on the ingenuity of the patent attorney in drafting the claim, by, for example, including in the claim the recitation of a physical step or the implementation of a particular machine.  Indeed, the concurring opinion in Classen admits as much, stating:  “[E]ligibility restrictions usually engender a healthy dose of claim-drafting ingenuity.  In almost every instance, patent claim drafters devise new claim forms and language that evade the subject matter exclusions.”

Thus, as in the software field, enlisting the help of a creative patent attorney may increase the chance that a  life science invention will be patentable subject matter.

Finally, it probably goes without saying, but I’ll say it anyways.  Patent eligibility is a rapidly evolving area of the law and I encourage all that are interested to continue monitoring court decisions in this area.  Indeed, the Supreme Court will hear oral argument in yet another patentable subject matter decision in December and it will be important to hear what the court has to say on patent eligibility in the ensuing opinion.  The case is Prometheus Labs. Inc. v. Mayo Collaborative Serv. and the case involves the patentability of diagnostic patents.


This article is for general information only. The information presented should not be construed to be formal legal advice nor the formation of a lawyer/client relationship.

Shane Cortesi

Shane Cortesi

Shane Cortesi is a Nashville-based attorney who advises inventors, artists, and entrepreneurs on protecting and licensing their inventions, artwork, and other intellectual property. A 2005 graduate of The George Washington University Law School, Shane also holds a Master’s in Biotechnology from Northwestern University and a Bachelor’s in Zoology from Miami University.

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