Patent protection for processes is currently in a state of flux.  Only certain tangible subject matter are eligible for patent protection, and not laws of nature, scientific theories, mathematical algorithms in the abstract, natural phenomena or abstract ideas.  While one of the statutory classes of patentable subject matter is “new and useful processes,” not all processes are patentable.  Whether business methods and medical diagnostic methods can be patented has been, and continues to be, highly controversial. 

 

The Supreme Court may shed more light (or confuse the issue) on business methods.  It has agreed to review the Federal Circuit’s decision in In re Bilski, with a decision expected in the first half of 2010.  In particular, the Supreme Court will review whether the Federal Circuit erred by finding that a process must be tied to a particular machine or apparatus, or transform a particular article into a different state or thing (the M-or-T Test) and whether the Federal Circuit’s M-or-T Test, which effectively forecloses meaningful patent protection to many business methods, contradicts Congressional intent with respect to patents on methods of doing or conducting business.  How the issues in this case are resolved by the Supreme Court could have serious implications on business method patents and could drastically affect medical diagnostic methods as well.

 

 

Inventions related to business methods are typically claimed as a series of steps, i.e., a process, with one or more of these steps often performed using a computer.  The decision rendered by the Federal Circuit in Bilski set forth that for processes to be eligible for patent protection they must satisfy at least one prong of the M-or-T Test.  The Federal Circuit, however, expressly declined to comment in Bilski on whether a computer could meet the definition of a particular machine or apparatus.

 

The U.S. Patent and Trademark Office (PTO) recently published New Interim Patent Subject Matter Eligibility Examination Instructions (“SME Instructions”).  The SME Instructions embrace the Federal Circuit’s Bilski decision, requiring that to be eligible for patent protection process claims must either: (1) be machine implemented, or (2) transform a particular article.  The SME Instructions additionally set forth two corollaries to the M-or-T test.  First, the particular machine or transformation must impose a meaningful limitation in the invention as claimed and, second, the particular machine or transformation must involve more than insignificant “extra solution activity.”  Thus, it is no longer sufficient in the PTO’s view to insert a step such as presenting a result on a display (an extra solution activity and possibly meaningless), which had previously been a technique for overcoming subject matter eligibility rejections raised by the PTO.  The SME Instructions, however, do provide guidance on the recitation of a computer in a process claim stating a “general purpose computer may be sufficiently ‘particular’ when programmed to perform the process steps.” 

 

In view of the above, we provide some recommendations for protecting business methods during this period of flux.  First, consider ways in which the business method may be characterized to transform articles or how a particular machine such as a computer may be incorporated into the business method in order to satisfy the M-or-T Test.  Second, provide support for the transformation and/or particular machine in the specification of newly filed applications and consider filing a continuing application to add such support to existing applications.  Finally, incorporate features necessary to satisfy the M-or-T test into the claims of the application.

 

 

Typically, patent applications claiming methods of diagnosis recite the basic steps of gathering data from a patient sample, comparing the data with a standard, and generating information about or diagnosing the patient based on the comparison. 

 

The Federal Circuit addressed the question of whether such medical diagnostic methods can constitute patent-eligible subject matter on two occasions post-Bilski.  In Classen Immunotherapies, Inc. v. Biogen Idec, the Federal Circuit affirmed a district court’s grant of summary judgment that certain claims were invalid as directed to ineligible subject matter.  The claims at issue covered a method for determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder, and included a step of immunizing a patient in accordance with an immunization schedule, followed by interpreting the incidence, prevalence, frequency or severity of a chronic immune-mediated disorder compared with a control group.  The Federal Circuit found (but did not further explain) that such claims were not tied to a particular machine or apparatus and did not transform a particular article into a different state or thing, thereby failing the M-or-T Test.

 

More recently, the Federal Circuit held in Prometheus v. Mayo that claims directed to a method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder satisfied the M-or-T Test and thus represented patent-eligible subject matter.  The claims included a step of administering a drug to a subject, followed by determining the level of the drug’s metabolite in that subject.  Both steps, which the district court characterized as merely data-gathering steps, were found by the Federal Circuit to be transformative and not insignificant extra-solution activity.  In particular, the Court determined that the human body is transformed upon administration of the drug.  Although the claims included additional steps utilizing the information obtained in the “measuring” step, the Federal Circuit concluded that, looking at the claims as a whole, the addition of such steps did not remove the claimed method from the realm of patent-eligible subject matter. 

 

Although the SME Instructions issued by the PTO do not specifically discuss medical diagnostic method claims, they do advise examiners to reject method claims if they do not tie at least one step to a particular machine or if they do not confer a different function or use on the data they manipulate.  Thus, one possible solution to the problem of patenting medical diagnostic methods is to include claims that specify that a comparing step is carried out using a computer programmed to compare gathered data with a standard.  An alternative solution may be to include a step of treating a specific condition in the patient consistent with a diagnosis.  Such a treatment step is arguably transformative in view of the Mayo decision because of the change in the physical state of the patient as a result of the treatment step.  Still another approach, as suggested by Mayo, is to include in the claims a step where either a drug or other substance is administered to a patient in connection with diagnosing the patient and/or a step where a sample from the patient is analyzed in some way. 

 

 

The question of exactly what does and what does not constitute patent eligible subject matter is likely to remain unclear, even after the Supreme Court renders a decision in the Bilski case.  Additionally, it will likely continue to be challenging to develop a single claiming strategy that can be successfully applied in every situation to ensure that a claim will be considered to embrace eligible subject matter.  Including steps that involve a physical transformation of some kind or the use of a specific type of machine clearly will be helpful.  However, the overall number of steps recited in a claim should be kept to the minimum considered necessary to render the claimed subject matter patent eligible, so as to increase the breadth of the claim and the likelihood that a single party would practice all the steps required by the claim.  Moreover, patent applicants should present claims of different scope so that if the broadest claims are later successfully challenged as failing to meet the subject matter eligibility requirements, narrower claims with additional steps or components suggested by Bilski or Mayo may still be valid and enforceable against infringers.