Under Mayo v. Prometheus, the U.S. Supreme Court reiterated that the machine or transformation test is merely a clue.  Eligibility of patent protection does not turn on the machine or transformation test.  Rather, the US Supreme Court provided the following analytical framework to determine whether a claimed invention is eligible for patent protection.  The preliminary assumption is that all inventions to a certain degree rely on one or more fundamental laws of nature.  However, the claim must not be too broad so as to preempt the use of a natural law of nature.  The claims must be examined so as determine whether those elements or combination of elements other than the fundamental law of nature contain an inventive concept.

In Mayo, the claim language which was determined to be ineligible for patent protection is instructive on applying this analytical framework.  In particular, the invention in Mayo was related to a drug which was metabolized differently by different people.  As a result, a single strength for the general population was effective for some but not everyone.  The invention contemplated utilizing a diagnostic test to determine how the particular patient metabolized the drug and altering the prescription based on the results of the diagnostic test.  The claims recited the specific ranges of the diagnostic test which indicated when the prescription should be increased or decreased.  It appears that the Court recognized the specific ranges as being a natural law of nature, or in other words, a description of how the body metabolized a particular drug.

In the prior art, all aspects of the claimed method were known except for the specific ranges.  In analyzing whether the claimed invention was eligible for patent protection, the Supreme Court compared the prior art to the claimed invention without regard the particular ranges and held that no inventive concept was being claimed.  All steps in the claimed method were well known in the prior art.  Hence, the invention was not eligible for patent protection.

The opinion also instructed against including as patent eligible an invention merely because the claimed invention is limited to a particular technological environment or included an insignificant post solution activity.

In response to the Mayo decision, it is important that one have a clear definition of the invention and provide a layered approach to drafting a patent application.  A broad claim should still be included and that might be rejected as being ineligible for patent protection.  However, other claims specifically focusing on the steps and not the basic law of nature should be included.  Patent applications should still be drafted as broad as possible but it should be layered until the specific embodiment disclosed by the inventor is disclosed in the patent application.  This is especially true for method claims and those claims which appear to be directed to a known causal relationship, rule of thumb or other mere discovery.

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In In re Ferguson, Applicants submitted a claim directed to a method (i.e., process) of marketing a product. The Court analyzed whether the claimed invention passed the machine or transformation test. The closest claim limitation relating to a machine was the phrase “marketing force”. As defined in In re Nuijten, (Fed. Cir. 2007), a machine is a concrete thing, consisting of parts, or of certain devices and combination of devices. Based on this definition of machine, the Court refused to characterize “marketing force” as a machine or apparatus. The claimed invention also did not transform a particular article. Hence, the Court affirmed that the method claim was directed to subject matter ineligible for patent protection.

The Applicants also submitted a claim directed to a “paradigm” for marketing software. The Court analyzed whether the “paradigm” claim fit within one of the four categories of patent eligible subject matter. The Applicants pointed to the “company” limitation as being a “machine.” The Court refused to characterize “company” as a “machine” since “company” does not fit within the definition of “machine” as discussed above. The Applicants also conceded that a company cannot be touched. Hence, the Court affirmed that the paradigm claim is directed to subject matter ineligible for patent protection.

Basic Background: During examination of a non provisional patent application, an examiner reviews the application to determine whether the claims are directed to subject matter that can be patented (i.e., eligible for patent protection). If the claims are directed to subject matter ineligible for patent protection, then the examiner will reject the claims.

35 USC Section 101 defines the types of subject matter eligible for patent protection. This section states that “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” Only inventions directed to the four types of subject matter (i.e., process, machine, manufacture, or composition of matter) are eligible for patent protection.

Ex Parte Halligan: Recently, the Federal Circuit which is the appeals court for all patent matters explained in In Re Bilski (Fed. Cir. 2008) the types of process claims eligible for patent protection. The patent appeals court stated that only processes that pass the “machine or transformation” test are eligible for patent protection.

Ex Parte Halligan (BPAI 2008) is an appeal from an examiner’s rejection of process Claim 119 as being subject matter ineligible for patent protection. Claim 119 is directed to a “programmed computer method” implemented using an unspecified algorithm. The Applicant filed an appeal with the Board of Patent Appeals and Interferences (BPAI) which is the administrative appeals board for patent matters within the Patent Office.

The BPAI analyzed whether the programmed computer method is eligible for patent protection under the machine or transformation test as interpreted by the Federal Circuit in In Re Bilski. The BPAI held that process Claim 119 is not eligible for patent protection even though it was tied to a computer (i.e., machine) because merely tying the method to a computer did not impose meaningful limits on the claim’s scope to impart patent eligibility. The “programmed computer” limitation is a field of use limitation insufficient to render an otherwise ineligible process claim patent eligible.

In In Re Bilski, the Federal Circuit rejected numerous tests that were used in various judicial opinions. The Federal Circuit held that the test to use is the machine-or-transformation test which states that a process is eligible for patent if: “(1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.” In Re Bilski, 2007-1130 (Fed. Cir. 2008).

The Federal Circuit expressed two corollaries for the machine-or-transformation test: (1) a process that preempts an entire field is not eligible for patent protection and (2) insignificant post solution activity will not transform an unpatentable principle into a patentable process.

In the present case, the inventor attempted to patent a method of resolving a legal dispute between two parties by the decision of a human arbitrator. The patent application presented two different sets of claims. The first set did not require the use of a mechanical device such as a computer. The second set required that the access step of the method be established through the internet, intranet, world wide web, software applications, telephone, television, cable, video [or radio], magnetic, electronic communication, or other communication means.

The court held that the first set claims the use of a mental process to resolve a legal dispute. Hence, the first set does not claim patentable subject matter. In contrast, the court held that the second set of claims does not include the mere use of a machine to collect data but combines the use of machines with a mental process, and thus, the second set claims patentable subject matter. In re Comiskey, Fed. Cir., No. 2006-1286, 9/20/07.

Bristol-Myers contended that although the method of administering the drug Paclitaxel is old, the method for administering the drug Paclitaxel for antitumor purposes is new and thus patentable. The Federal Circuit disagreed, stating that “the claimed method is not directed to a new use; it is the same use, and it consists of the same steps as described by the Kris reference. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.” Id. (emphasis added). Accordingly, the patent claims were invalidated.

In Abbott Laboratories v. Baxter Pharmaceutical Products, Inc., Fed. Cir., No. 06-1021, 11/10/06, the patentee patented a composition (i.e., product claim) comprising water and Sevoflurane to prevent degradation of the Sevoflurane in the presence of Lewis acid. Sevoflurane is an inhalation anesthetic. A prior art reference disclosed the water and the Sevoflurane composition but did not appreciate the benefit of water to prevent the degradation of Sevoflurane in the presence of Lewis acid. The patentee contended that the prior art reference did not anticipate their claims because the claimed composition is directed to a newly discovered result of a known process directed to a different purpose citing Bristol-Myers Squibb for support. Even though Bristol-Myers Squibb involved only method claims, the patentee attempted to extend the holding of Bristol-Myers Squibb to product claims. The Federal Circuit disagreed by narrowing the holding of Bristol-Myers Squibb to method claims and did not retain the broad reading of Bristol-Myers Squibb to include product claims as desired by the patentee. Hence, the composition claims at issue were anticipated, and thus, invalid.