In an article posted on their law firm’s web site, patent attorneys Stephen D. Harper, PhD, and Stephen J. Weed in the Valley Forge, PA, office of RatnerPrestia consider the U.S. Supreme Court’s current deliberation of the Federal Circuit’s decision on business methods in In re Bilski and possible patent protection strategies during this “period of flux.” The Supreme Court is reviewing 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 machine-or-transformation test) — and whether the Federal Circuit’s M-or-T test contradicts Congressional intent with respect to patents on methods of doing or conducting business. The Supreme Court’s decision, expected by July, could have serious implications not only on business method patents but also on medical diagnostic methods, Harper and Weed contend.
Inventions related to business methods are typically claimed as a series of steps, with one or more steps often performed using a computer. The decision rendered by the Federal Circuit in Bilski set forth that processes must satisfy at least one prong of the M-or-T test to be eligible for patent protection. 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”) [that] embrace the Federal Circuit’s Bilski decision,” Harper and Weed write. The SME instructions require that, to be eligible for patent protection, process claims must either: 1) be machine implemented or 2) transform a particular article. The SME Instructions also set forth two corollaries to the M-or-T test: 1) the machine or transformation must impose a meaningful limitation in the invention as claimed and 2) the particular machine or transformation must involve more than insignificant “extra solution activity.” In the PTO’s view, it is no longer sufficient to insert a step such as presenting a result on a display. However, the SME instructions provide guidance on the recitation of a computer in a process claim, stating that a “general purpose computer may be sufficiently ‘particular’ when programmed to perform the process steps,” the attorneys write.
In view of that interim guidance, 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, Harper and Weed suggest. Second, provide support for the transformation and/or particular machine in the specifications 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.
Though most observers have focused attention on the case’s impact on software patents, innovations in the diagnostics space are also affected, the attorneys note. Patent applications claiming methods of diagnosis typically 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, Harper and Weed add. 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 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 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.
“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,” Harper and Weed write. “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. 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.”
Source: Ratner Prestia
| Editor’s note: The January issue of Technology Transfer Tactics includes an in-depth article offering specific advice for TTOs on preparing for Bilski and taking steps to optimally protect their affected IP. CLICK HERE for subscription information. |