Interim USPTO Examination Instructions For Evaluating Subject Matter Eligibility Under 35 U.S.C. 101 in Light of the Supreme Court Bilski Decision.
The Patent and Trademark Office (“USPTO”) in August 2007 released examination instructions (“Guidelines”) (available here) for patent examiners to implement the U.S. Supreme Court’s decision in Bilski v. Kappos, 130 S. Ct. 3218, 177 L. Ed. 2d 792 (2010) (available here). The Guidelines state there are two criteria for determining subject matter eligibility under the Patent Statute 35 U.S.C. 101. The statute permits an applicant to obtain a patent on “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Id. The Guidelines state that the claimed invention (1) must be directed to one of the four statutory 101 categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. The claimed invention is defined in the patent application claims at the end of the patent specification.
Many commentators recognize that the Bilski Supreme Court case did not provide any guidance to what is and what is not patentable under Section 101 (holding that the Bilski claims covered an abstract idea without explaining what are the parameters of an abstract idea). The Guidelines attempt to fill in the blanks on this issue. The Guidelines state that Section 101 is satisfied by a:
i. Process which is an act, or a series of acts or steps that are tied to a particular machine or apparatus or transform a particular article into a different state or thing.
ii. Machine which is a concrete thing, consisting of parts, or of certain devices and combination of devices. This includes every mechanical device or combination of mechanical powers and devices to perform some function and produce a certain effect or result.
iii. Manufacture which is an article produced from raw or prepared materials by giving to these materials new forms, qualities, properties, or combinations, whether by hand labor or by machinery.
iv. Composition of matter which includes all compositions of two or more substances and all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids.
However, certain claims are not directed to one of the statutory 101 categories. Examples of such claims are:
i. Transitory forms of signal transmission (for example, a propagating electrical or electromagnetic signal per se).
ii. A naturally occurring organism.
iii. A human per se.
iv. A legal contractual agreement between two parties.
v. A game defined as a set of rules.
vi. A computer program per se.
vii. A company.
A claim that covers both statutory and non-statutory embodiments (under the broadest interpretation of the claimed invention when read in light of the specification) is not eligible for patent protection and should be rejected under Section 101. As for process claims, when a machine or article is inherently recited in the process claims, but not explicitly recited or required by the claimed method, and the record of the prosecution as a whole does not make clear that the method involves a particular machine or a particular article, “the examiner should identify the inherent machine on the record [and] the record should also be clear as to which step (or steps) invokes the machine or article.” This guidance effectively requires the patent applicant to identify on the record in an amendment or a response to an examiner’s Office Action rejection what is the “machine or transformation” present in the claimed process.
“When a judicially recognized exception is present in the claim, [the examiner should] determine if the claim recites structural limitations for it to qualify as a practical application of the judicial exception. A manmade tangible embodiment with a real world use is evidence of a practical application.” If the claim covers substantially all practical uses of the judicial exception, the patent claim preempts the topic and is not patentable under Section 101. Judicially recognized exceptions to Section 101 are: abstract ideas, mental processes, laws of nature and natural phenomena, and are sometimes further described as physical phenomena, scientific principles, systems that depend on human intelligence alone, disembodied concepts, and disembodied mathematical algorithms and formulas. Per the USPTO, “the exceptions reflect the courts’ view that the basic tools of scientific and technological work are not patentable.”
The USPTO also adopts the machine-or-transformation test (M or T test) proposed by the Federal Circuit Court of Appeals case in Bilski (available here). “A process claim, to be statutory under § 101, must pass the machine-or-transformation test (M or T test), which ensures that the process is limited to a particular practical application.” To pass the M or T test, the claimed process must: “(1) be tied to a particular machine or apparatus (machine implemented); or (2) particularly transform a particular article to a different state or thing.” The Guidelines include flow charts to assist the patent examiners.